Statement for Outside of USA Customers

Statement for Outside of USA Customers

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

Dear Healthcare Professional,
This statement is to inform PENTAX Medical customers outside of USA about our
voluntary recall/corrective action in the USA on ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-rings, and distal end covering that has been announced on February 7th, 2018.

Overview of Field Actions in the USA:

• Starting in January 2017, PENTAX Medical informed ED-3490TK customers about a potential issue associated with the distal end of the ED-3490TK. The customer letter offered recommendations intended to reduce the potential risk for contamination and subsequent patient injury and also informed customers that PENTAX Medical would be conducting a duodenoscope inspection process of the distal tip.
• On February 7, 2018 FDA announced the 510(k) clearance of the ED-3490TK updated design and PENTAX's voluntary recall/corrective action 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. See FDA’s website on https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm595603.htm
• See also the announcement on PENTAX Medical website https://www.pentaxmedical.com/pentax/en/99/1/Customer-notices

Information for Outside USA Customers:

PENTAX Medical will initiate a Field Safety Corrective Action (FSCA) as part of our commitment to maintaining patient safety and quality.

PENTAX Medical will issue additional customer 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 the action, please feel free to contact your local PENTAX Medical representative.

Sincerely,
PENTAX Medical