Customer Information

  • Customer Information on Petya Ransomware for PENTAX Medical Informatics, Speech, Voice and Swallowing Systems

    Description
    We recognize our Informatics, Speech, Voice and Swallowing Systems are impacted by the Petya ransomware virus.  Petya is designed to spread rapidly among computers on the same network, encrypt files on the infected system, empowering the attackers to demand ransom from users to decrypt the files.  Similar to the WannaCry virus, Petya uses the “EternalBlue” exploit against the Windows’ Server Message Block (SMB) protocol.

    Recommendations 
    Those customers who installed Microsoft security patch MS17-010 are not at risk from Petya; however, for those customers who have yet to install this patch, we recommend the installation of this patch to help safeguard their PENTAX Medical systems listed below.  More details and instructions are on Microsoft’s Security Bulletin at:  https://technet.microsoft.com/en-us/library/security/ms17-010.aspx .

    In addition, Microsoft has released new security patches via the June 2017 security update. This security update is meant to prevent other possible Windows’ exploits from occurring.  These patches can be referenced in the Microsoft Security Advisory (MSA) 4025685 at:  https://technet.microsoft.com/en-us/library/security/4025685.aspx . The PENTAX Medical systems listed below support the MSA 4025685 patches.

    Systems that support the Microsoft Security Advisory 4025685

    Systems that support the Microsoft Security Advisory 4025685

     

    In case these products are operated in a stand-alone mode, there is no impact of the ransomware virus and there is no need to apply the security patch.

    There is no impact on other products than the listed above in case they are operated in a stand-alone mode, but in case they are used in a network, we recommend to ensure the Windows PCs’ are updated.

    If you have any questions, please contact your local PENTAX Medical representative.

    Sincerely,

    PENTAX Medical

  • URGENT MEDICAL DEVICE REMOVAL 18-009 FG-1017 Gen 2 Pentax Medical CryoBalloon™ Controller

    Dear Healthcare Professional,

    This letter is to inform you that PENTAX Medical is conducting a recall/corrective action for the FG-1017 C2 CryoBalloon™ Controller.  Pentax Medical is performing a removal of the affected products and recommends that affected products should not be used.  Please ensure that all potential users in your facility are made aware of this notification and the recommended actions. 

    Product Issues

    PENTAX Medical has become aware of an issue  which affects the FG-1017 C2 CryoBalloon™ Controller (lot numbers as listed below).  It has been noted that the Controller does not detect overpressure in the balloon during the application of non-dosing puff’s of Nitrous Oxide.  This can contribute to balloon over pressurization if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.

    Affected Product Details

    Model

    Description

    Lot Numbers

    FG-1017

    C2 CryoBalloon Controller

    All

    Occurrence and Safety

    Controller Balloon over-pressure detection.  There has been one reported case of occurrence due to the use of a severely kinked catheter for ablation where the vent lumen was significantly occluded.  There are currently a total of 36 Controllers remaining in distribution in the USA. If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur.

    Customer Instructions

    Enclosed with this letter is a Field Action Response Form identifying the affected device(s), (lot number and quantity) which have been sold to your facility.  Please forward this letter and the enclosures to the department where the above referenced items are used.  The end user of the affected products should:

    1. Complete, sign, and return the Field Action Response Form by either of the following methods;

    - Fax to PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or

    - Email a pdf copy to customeradvisories@pentaxmedical.com

    2. Send a copy of the completed Response Form with the return material using the enclosed label to;

    Pentax of America Inc,
    303 Convention Way Suite 1
    Redwood City, CA 94063
    Attention: 2018-009-R Action

    Contact Information

    If you have any questions regarding this action, please contact PENTAX Medical Customer Service.

    Tel:       650-318-5899 (8:30 AM – 5:00 PM, Monday – Friday, PST)       

    Fax:      650-318-5899

    Email:   RMA@C2Therapeutics.com

     

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we provide replacement devices. Please be assured that maintaining patient safety and quality is our utmost priority.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

     

    Sincerely, PENTAX Medical Regulatory Affairs

  • URGENT MEDICAL DEVICE REMOVAL 18-007 Gen 2 Pentax Medical CryoBalloon™ Catheters: FG-1028 Focal Standard, FG-1024 Standard Focal Pear, and FG-1030 Standard 90

    Dear Healthcare Professional,

    This letter is to inform you that PENTAX Medical is conducting a recall/corrective action for Gen 2 C2 CryoBalloon™ Catheters:FG 1028 Focal Standard, FG-1024 Standard Focal Pear, and FG 1030 Standard 90 for Lot numbers as listed below.  Pentax Medical is performing removal of the affected products and recommends that affected products should not be used.  Please ensure that all potential users in your facility are made aware of this notification and the recommended actions. 

    Product Issues

    PENTAX Medical has become aware of an issue which affects Gen 2 CryoBalloon™ Catheters, catalog numbers; FG-1028, FG-1024, and FG-1030 This issue is attributed to the catheter RFID tag not being correct or not being correctly or completely readable by the controller.  Being that an incorrect default dose and dose increments may be transmitted to the controller it is possible that the User would not notice the inconsistency and may treat the patient using a significantly higher dose than intended.

    Affected Product Details

    Model

    Description

    Lot Numbers

    FG-1028

    Gen 2 CryoBalloon Catheter, Focal Standard

    06152018-02,  06252018-03,  07062018-01,  07232018-02, 08102018-01,  08172018-06,  08292018-04,  9172018-01

    FG-1024

    Gen 2 CryoBalloon Catheter, Standard Focal Pear

    06152018-01,  07172018-02,  07022018-04,  08212018-01,  08102018-03

    FG-1030

    Gen 2 CryoBalloon Catheter, Standard 90

    08062018-03

    Occurrence and Safety

    RFID Tag dose values.  There have been (3) reported cases to date in which the Gen 2 CryoBalloon™ Catheter FG-1028 exhibited the RFID Dose error described above.  This occurred in 3 out of 239 units shipped since August 17th 2018. This is 3/239 or 1.2% of the distributed population.There are currently a total of 195 units for FG-1024, FG-1028, and FG-1030 remaining in distribution in the USA, many of which may not exhibit the issue and may already have been used, discarded or returned.  If a patient is exposed to longer than desired cryoablation, adverse events such as bleeding, esophageal stricture or perforation may occur.  

    Customer Instructions

    Enclosed with this letter is a Field Action Response Form identifying the affected device(s), (lot number and quantity) which have been sold to your facility.  Please forward this letter and the enclosures to the department where the above referenced items are used.  The end user of the affected products should:

    1. Complete, sign, and return the Field Action Response Form by either of the following methods;

    - Fax to PENTAX Recall Coordinator at 201-799-4063 (alternate 201-391-4189) or

    - Email a pdf copy to customeradvisories@pentaxmedical.com

    2. Send a copy of the completed Response Form with the return material using the enclosed label to;

    Pentax of America Inc,
    303 Convention Way Suite 1
    Redwood City, CA 94063
    Attention: 2018-007-R Action

    Contact Information

    If you have any questions regarding this action, please contact PENTAX Medical Customer Service.

    Tel:       650-318-5899 (8:30 AM – 5:00 PM, Monday – Friday, PST)       

    Fax:      650-318-5899

    Email:   RMA@C2Therapeutics.com

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we provide replacement devices. Please be assured that maintaining patient safety and quality is our utmost priority.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

     

    Sincerely,

    PENTAX Medical Regulatory Affairs

  • URGENT MEDICAL DEVICE CORRECTION AND REMOVAL 18-001 for United States Customers Only of PENTAX Medical Duodenoscope Model ED-3490TK

    Re: PENTAX Medical Duodenoscope Model ED-3490TK
    Replacement of Forceps Elevator Mechanism, O-Rings, Distal End Covering, and Operation Manual Update

     

    Dear Healthcare Professional,

    This letter is to inform you that PENTAX Medical (“PENTAX”) is conducting a voluntary recall/corrective action of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-rings, and distal end covering. In January 2017, PENTAX informed ED-3490TK customers about a potential issue associated with the distal end of the ED-3490TK. The January 2017 customer letter offered recommendations intended to reduce the potential risk for contamination and subsequent patient injury and also informed customers that PENTAX personnel would be conducting a no-charge duodenoscope inspection process of the distal end covering.

    The ED-3490TK duodenoscope is a flexible gastrointestinal endoscope used in procedures such as endoscopic retrograde cholangiopancreatography (ERCP). PENTAX has worked closely with the U.S. Food and Drug Administration (FDA) to mitigate the potential risk of infection in flexible endoscopy, and is conducting this field action with the knowledge of the FDA.

    On February 7, 2018, FDA cleared an updated design for the ED-3490TK duodenoscope (K161222). The current voluntary recall/corrective action is being taken to replace the forceps elevator mechanism, the O-rings, and the distal end covering with materials and processes consistent with the design features of the cleared updated ED-3490TK. In addition, a periodic duodenoscope inspection process is being implemented for the forceps elevator mechanism, and is described in the updated Operation Manual (S206 R00) which is enclosed with this letter. The updated information can be found on page 22 of the Operation Manual. The Reprocessing Instructions For Use (S041 R02) have not changed and should be closely followed.

    Customer Instructions:

    Enclosed with this letter is a new Operation Manual (S206 R00) and a Field Correction Response Form (MK-1065 Rev B). Please discard all old copies of the ED-3490TK Operation Manual, and replace with the new Operation Manual enclosed in this package. Additional copies of the Operation Manual can be downloaded from the PENTAX Medical (USA) website located at http://www.pentaxmedical.com/pentax/en/99/1/Customer-notices. The Reprocessing IFU has not changed.

    The response form identifies the serial numbers of the affected duodenoscopes which have been sold to your facility. Please complete this form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the ED-3490TK for the forceps elevator mechanism, O-rings and distal end covering updates. Loaner units will be supplied to customers as needed. You can continue to use your ED-3490TK duodenoscope until you are contacted to update your unit. PENTAX will continue to conduct distal tip inspections every 6 months on units that have not been updated.

    PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labeling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Operation Manual and Reprocessing IFU for these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. Additionally, PENTAX recommends that you immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. Continuing to use devices with integrity issues (i.e.; holes, cracks, kinks, and scratches) can contribute to persistent device contamination and subsequent patient infection.

    Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at vigilance@pentaxmedical.comand the FDA’s MedWatch Adverse Event Reporting program.

    Contact Information:                                                                                                                         

    PENTAX regrets any inconvenience that this action may cause and appreciates your understanding and cooperation. PENTAX will issue additional communications as further information becomes available. Please be assured that maintaining patient safety and quality is our utmost priority.

    If you have any questions regarding this action, please feel free to contact us at:

    Tel: 1-800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax: 201-799-4063 (alternate 201-391-4189)
    Email: customeradvisories@pentaxmedical.com

     

    Sincerely,

    PENTAX Medical

     

    ED-3490TK Operation Manual
    ED-3490TK Elevator & O-Ring Field Action Customer Letter
    ED-3490TK Field Correction Response Form

    MK-1062 Rev B

  • U.S. URGENT RECALL LETTER 17-011 Video Cystoscope Product Removal for United States Customers Only

    July 12, 2017

    Dear Valued Customer,

    The Video Cystoscopes (ECY-1570 and ECY-1570K) have been discontinued and are no longer available for sale in the US. The ECY-1570 and the ECY-1570K were launched by PENTAX Medical in the US market in 2006. These video cystoscopes are used for detailed visualization of tissue structures in day-to-day urology. This recall has been initiated due to an outdated regulatory clearance. Use of this product will not likely cause any adverse events.

    PENTAX Medical has discontinued the sale and support of these endoscopes and to withdraw them from the US market. The products were released under a letter to file. PENTAX Medical has made a business decision not to make a 510(k) submission. These devices will continue to be sold and supported outside of the US. This change is effective immediately.

    Customers who acknowledge on the attached customer response form that they still own the models in question will be contacted by their PENTAX Territory Manager.

    Affected Product Details:

    Product: Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    Instructions for Use: Z845 Revisions 13 and 14 (R13 and R14)

    Customer Instructions:

    Customers should inspect their stock of PENTAX Medical ECY-1570 and ECY-1570K video cystoscopes, quarantine them, and discontinue use of these products.  If you have sold and distributed these products, please provide a copy of the notice and response form to the new owners.

    Enclosed with this letter is a customer response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. The attached form should be completed and returned to PENTAX Medical.

    Contact Information

    If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service.

    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)    

    Fax:        201-799-4063 (alternate 201-391-4189)

    Email:    customeradvisories@pentaxmedical.com

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.
    Department of Quality Assurance and Regulatory Affairs

    Supplementary Documents

    Video Cystoscope Customer Response Form

    Video Cystoscope FSCA Letter

  • U.S. URGENT FIELD CORRECTION 17-003 Notification of Update to Instructions for Use (IFU) Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    May 23, 2017

    Dear Valued Customer,

    PENTAX Medical has become aware of an error in the Instructions for Use (IFU) for ultrasound video gastroscope models EG-3670URK and EG-3870UTK.  Please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions.

    Affected Product Details:

    Product: Ultrasound Video Gastroscope Models EG-3670URK and EG-3870UTK

    Instructions for Use: Z845 Revisions 13 and 14 (R13 and R14)

    Safety Instructions:

    Although no incidents related to this error have been reported to PENTAX Medical, please be informed about the following error and correction:

    Table 1:

    Page

    Error

    Correct

    p70

    WARNING:

    The cleaning detergent solution should remain in contact with the ALL internal channels and external endoscope surfaces for the time period recommended by the manufacturer of the disinfectant.

    WARNING:

    The disinfecting solution must remain in contact with the ALL internal channels and external endoscope surfaces for the time period recommended by the manufacturer of the disinfectant.

    Customer Instructions:

    In order to ensure the proper use and cleaning of the affected PENTAX endoscopes, please have users read and carefully follow the IFU addendum that is included with this letter.  If a new IFU is needed, please visit PENTAX Medical’s IFU portal (https://ifu.pentaxmedical.com/welcome-to-pentax-medical/). We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Also enclosed with this letter is a field correction response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  The end user of the affected products should complete this form and return it to PENTAX Medical.

    Contact Information

    If you have any questions regarding this action, please feel free to contact PENTAX Medical Customer Service.

    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)    

    Fax:        201-799-4063 (alternate 201-391-4189)

    Email:    customeradvisories@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,
    PENTAX of America Inc.
    Director of Regulatory Affairs

    Enclosures:

    Customer Response Form, Control Number MK-951                                      
    Ultrasound Gastroscope IFU (Z845) Addendum, MK-958 Rev. A

    For a PDF copy of this Urgent Field Correction letter, please click here.

    Supplementary Documents

    Field Correction Response Form (MK-951)

    IFU Addendum Z845 R3 and R14 

  • U.S. URGENT FIELD CORRECTION 16-016 Revised Instructions for Use of PENTAX Medical Rigid Laryngostroboscopes Models 9106 and 9108

    December 12, 2016

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical is issuing a new instructions for use (IFU) for two rigid laryngostroboscopes models – 9106 and 9108. This new IFU clarifies the reprocessing instructions in order to ensure that customers are aware of the best methods for cleaning their 9106 and 9108 laryngostroboscopes. Formerly, the reprocessing instructions for these endoscopes were included within the operator manual for the PENTAX Medical Stroboscopy System or 9310HD Recording Module.

    Identification of Affected Endoscope Models

    Table 1 provides an overview of the historical and revised IFUs containing instructions for 9106 and 9108 laryngostroboscopes.

    Instructions Regarding IFUs
    Please ensure that all users read and carefully follow the revised IFU in order to properly operate and reprocess the affected PENTAX endoscopes. The reprocessing instructions in the revised IFU supersede those the above referenced operator manuals. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a field correction response form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility. Please forward this letter and the enclosures to the department in which the above referenced items are in use. It is suggested that the end user of the affected endoscopes complete this form and return it to PENTAX.

    Please be aware that you must return the completed form even if you no longer possess these PENTAX endoscopes. Your local sales representative can assist you in completing this form. This information is essential in order to maintain field correction effectiveness information required by law.

    Contact Information
    If you have any questions regarding this action, please feel free to contact us at:
    Tel:         800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:        201-799-4063 (alternate 201-391-4189)
    Email:   customeradvisories@pentaxmedical.com
    This field correction is being made with the knowledge of the U.S. Food and Drug Administration.
    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.
    Department of Quality Assurance & Regulatory Affairs

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001415)
    Rigid Scope IFU D04-IFU-0001400 Rev. B
    Rigid Scope FSCA Letter (MK-869)

  • U.S. URGENT FIELD CORRECTION 16-015 Revised Operation and Reprocessing Instructions for Use of PENTAX Medical Video Nasopharyngolaryngoscopes Models VNL-1190STK and VNL-1590STI

    September 21, 2016

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical is issuing a new combined operation and reprocessing instructions for use (IFU) for three diagnostic video-nasopharyngolaryngoscope models – VNL-1070STK, VNL-1190STK, and VNL-1590STI.  This new combined IFU reflects changes to the scopes’ intended use, model name and number, and sterilization method as well as additional clarifying detail to the operation and reprocessing instructions.  

    Revised Labeling and Instructions

    The following is an overview of the main changes to the labeling and IFU:

    • Removed all references to video-nasopharyngolaryngoscopes or VNL models and replaced them with video laryngostroboscopes or VLS models.
    • Updated the intended use statement. The revised IFU clarifies that the scopes are intended to provide optical visualization (via video monitor) of the laryngeal and pharyngeal area in order to observe glottic action with the use of a stroboscopic light source. These instruments are introduced via the mouth or the nose, as decided by physician, when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
    • Added references to EPK-i5010, and removed references to EPK-p to reflect changes to the portfolio of processors currently used in the United States.
    • Updated the sterilization section to refer to Steris System 1E Liquid Chemical Sterilant.
    • Removed references to endoscopes not covered by this change.
    • Updated to add additional detail to the cleaning instructions, cleaning agents, and high level disinfectants.

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, the new model numbers, and the document number and revision number for the historical and revised IFUs. The accompanying USB flash drive contains the revised IFU identified below. Please distribute only those IFUs which support the products owned by your facility. If there are any technical challenges with accessing the IFU on the flash drive, a copy of the file is available on the PENTAX Medical website at https://pentaxmedical.com/pentax/en/99/1/News.

     

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and that all users read and carefully follow the Revised IFU in order to properly operate and reprocess the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the affected endoscopes (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  It is suggested that the end user of the affected endoscopes complete this form and return it to PENTAX.

    Please be aware that you must return the completed form even if you no longer possess PENTAX endoscopes.  Your local sales representative can assist you in completing this form. This information is essential in order to maintain field correction effectiveness information required by law.

    Contact Information

    If you have any questions regarding this action, please feel free to contact us at:

    Tel:       800-431-5880 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:      201-799-4063 (alternate 201-391-4189)
    Email:   recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001415)
    Video Laryngostroboscopes Operation & Reprocessing IFU (S118 R00)
    VLS Product Labeling Change Notice (MK-862)

     

  • U.S. URGENT FIELD CORRECTION16-009/010 Revised Instructions for Use of PENTAX EB-1970UK, EB-70K, and 75K Series Video Bronchoscopes

    May 31, 2016

    Dear Valued Customer,

    In April 2014, PENTAX Medical received clearances from the FDA for modifications to the Operation and Reprocessing Instructions for Use (IFU) for the 70K and 75K series of video bronchoscopes and the EB-1970UK ultrasound video bronchoscope (“Affected Endoscopes”). These revised instructions have not been included in product shipments since the time of these clearances. PENTAX Medical is initiating this field action to provide customers that have purchased the Affected Endoscopes with the most recent Operation and Reprocessing IFUs. For your convenience, a USB flash drive containing electronic copies of the Operation and Reprocessing IFUs and accompanying addenda for the Affected Endoscopes is provided with this letter. These revised Operation and Reprocessing instructions should be implemented as soon as possible.

    Revised Instructions
    The instructions have been revised in the following manner:

    • Operation IFU
      • Integrated all models of each family into the IFU
      • Modified the indications for use language to be consistent with similar products
      • Enhanced the explanation of the operation of the device
      • Revised and added cautions and warnings
    • Reprocessing IFU
      • Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including:
        • number of brush and rinse steps
        • quantity of fluid volumes
        • use of additional text, figures, cautions, and warnings

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility.

    Table 1 - FSCA for EB and EBUS Scopes

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the Affected Endoscopes (Model and Serial Number) which have been consigned (sold, loaned, or leased) to your facility. Please forward this letter and the enclosures to the relevant department in your facility so that they may review the information provided and complete the response form. Please note that you must return the completed form even if you do not have any IFUs to discard. Your local sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by FDA.

    Contact Information
    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:

    Tel:       800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST) 

    Fax:      201-799-4063 (alternate 201-391-4189)

    Email:    recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-FLD-0001330 R00)

    Video Bronchoscopes Operation IFU (S015_R04)
    Video Bronchoscopes Reprocessing IFU (S020_R04)

    Ultrasound Video Bronchoscopes Operation IFU (S016_R02)
    Ultrasound Video Bronchoscopes Reprocessing IFU (S021_R04)

    IFU Addendum 388_R01
    IFU Addendum 392_R00

  • U.S. URGENT FIELD CORRECTION 16-011/012 Revised Operations and Reprocessing Instructions for Use of PENTAX 90-series Video Colonoscopes and 90-Series Video Gastroscopes

    August 15, 2016

    Dear Valued Customer,

    In April 2014, PENTAX Medical received clearances from the FDA for modifications to the Operation and Reprocessing Instructions for Use (IFU) for the 90-series of video colonoscopes and video gastroscopes (“Affected Endoscopes”). These revised instructions have not been included in product shipments since the time of these clearances.

    PENTAX Medical is initiating this field action to provide customers that have purchased the Affected Endoscopes with the most recent Operation and Reprocessing IFUs. For your convenience, a USB flash drive is provided containing electronic copies of the Operation and Reprocessing IFUs and accompanying addenda and bulletins. These revised instructions should be implemented as soon as possible.

    Some of the video colonoscope and video gastroscope models (see Table 2 below) have a forward water jet channel that requires an OE-C20 cleaning adapter.  Customers who need OE-C20 adapters can purchase them from PENTAX Medical for affected endoscope models by requesting part number KUM-OEC20-FCA.

    Revised Instructions
    The instructions have been revised in the following manner:

    • Operation IFU
      • Integrated all models of each family into the IFU
      • Modified the indications for use language to be consistent with similar products
      • Enhanced the explanation of the operation of the device
      • Revised and added cautions and warnings
    • Reprocessing IFU
      • Included more specificity regarding reprocessing activities to aid in the proper method for reprocessing the endoscopes, including:
        • number of brush and rinse steps,
        • quantity of fluid volumes,
        • use of additional text, figures, cautions, and warnings
      • Integrated use of OE-C20 adaptor

    Identification of Affected Endoscope Models
    Table 1 provides an overview of the Affected Endoscope models, and the part number and revision of the historical and revised IFUs. The accompanying USB flash drive contains all the revised IFUs identified below. Please distribute only those IFUs which support the products owned by your facility.

    EC and EG Video Scopes FSCA Table 1

    Instructions Regarding Historical IFUs
    Please ensure that user departments discard the prior versions of these Instructions for Use and ensure that all users read and carefully follow the revised Operation and Reprocessing IFUs to ensure the proper use and cleaning of the affected PENTAX endoscopes. We invite you to contact your PENTAX Medical sales representative to arrange for training regarding these new procedures.

    Need for OE-C20 Cleaning Adapter
    Table 2 is a chart of each 90-series video colonoscope and video gastroscope model, and whether that model has a forward water jet that requires an OE-C20 cleaning adapter.  

    EC and EG Video Scopes FSCA Table 2

    Response Form
    Enclosed with this letter is a Field Correction Response Form. The form identifies the Affected Endoscopes (Model and Serial Number) which have been sold to your facility. Please forward this letter and the enclosures to the relevant department in your facility so that they may review the information provided and complete the response form. Please note that you must return the completed form even if you do not have any IFUs to discard. Your local sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by FDA.

    Contact Information
    If you have any questions regarding this action, please feel free to contact Paul Silva, PENTAX Americas Recall Coordinator at:
    Tel:       800-431-5880 ext. 2064 (8:30 AM – 5:00 PM, Monday – Friday, EST)
    Fax:      201-799-4063 (alternate 201-391-4189)
    Email:   recall.coordinator@pentaxmedical.com

    This corrective action is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    To download a PDF copy of this Urgent Field Correction, please click here.

    Supplementary Documents
    Field Correction Response Form (F04-REG-0001384 R00)

    IFU Addendum: Correction to Operation & Pre-Cleaning Instructions for Endoscopes with Air/Water Channels (D04-IFU-0001206 Rev A)
    IFU Addendum (388_R01)
    IFU Addendum (392_R00)

    Video Colonoscopes Operation IFU (S017_R01)
    Video Colonoscopes Reprocessing IFU (S022_R04)
    Video Upper G.I. Scopes Operation IFU (S013_R01)
    Video Upper G.I. Scopes Reprocessing IFU (S019_R04)
    Video Colonoscopes and Accessories – Optional Manual Cleaning Procedures (MK-626 Rev D)
    Video Upper G.I.  Endoscopes and Accessories – Optional Manual Cleaning Procedures (MK-625 Rev D)

  • U.S. URGENT FIELD CORRECTION 17-002 Notification Regarding Requirement to Use Isolation Transformer for PENTAX Medical Models 7245C, 7245C/E, 7245D, 9200C, 9200D, 9310HD, and 9400

    Dear Valued Customer,

    The purpose of this communication is to inform you that PENTAX Medical has become aware that some customers may not have been provided with an isolation transformer when they purchased a PENTAX Medical computer system mounted to a cart. The electrical safety requirements for these systems requires the use of an isolation transformer to protect patients from electrical shock.  


    Identification of Affected Models

    Table 1 provides a list of the affected products.

    Table 1

    Model Number   Product Name
    7245C Computer Digital Video System
    7245C/E Computer Digital Video System 230v  
    7245D Computer Digital Video System
    9200C Digital Video Capture
    9200D Digital Video Capture Module
    9310HD HD - Digital Video Capture
    9400 Laryngeal Strobe


    Customer Instructions

    Enclosed with this letter is a field correction response form. The form identifies the affected computer systems (model and serial numbers) which have been sold to your facility.  Please forward this letter and the enclosures to the department in which the above referenced items are in use.  It is suggested that end user of the affected products complete this form and return it to PENTAX Medical.

    Check if the affected models in Table 1 are in use at your facility are currently connected to an isolation transformer.  The picture below shows the location of the isolation transformer on a sample PENTAX Medical cart.  If the affected product is in use and is NOT connected to an isolation transformer, an isolation transformer can be obtained from PENTAX Medical.  Please request model number ISO-PROMO when contacting PENTAX Medical. 


    Picture on an Isolation Transformer Mounted onto a Cart


    Isolation transformer located under rear of cart


    Contact Information

    If you have any questions regarding this action, please feel free to contact us at:

    Tel:         800-431-5880, select option 1 (ENT), then option 3 (equipment)
    Fax:        201-799-4063 (alternate 201-391-4189)
    Email:    customeradvisories@pentaxmedical.com

    This field correction is being made with the knowledge of the U.S. Food and Drug Administration.

    PENTAX Medical regrets any inconvenience that may result from this action and appreciates your patience as we introduce these updated instructions. Please be assured that maintaining patient safety and quality is our utmost priority.

    Sincerely,

    PENTAX of America Inc.

    Department of Quality Assurance & Regulatory Affairs

    Isolation Transformer FSCA Response Form (Editable) MK-897 

    Isolation Transformer FSCA Letter MK-896 Rev. B