—#151891

Product

URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

FDA product code: FBN — Choledochoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K912120
Affected lot / code info: All serial numbers are affected.

Why it was recalled

Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of patients that had to be surgically removed. In an effort to mitigate a potential risk to patient health, Olympus is undertaking this action to notify users of these complaints and the need for careful inspection of the endoscope prior to use in accordance with the instructions provided int heir notification letter.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus sent an Urgent Medical Device Safety Notice dated December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus that were taken to address the issue. Consignees were asked to inspect their inventory for the specified device, review the enclosed Instructions for Safe Use, which provided instructions to assist with understanding the Warnings and Cautions. You can contact our Technical Assistance Center (TAC) at 1-(800) 848-9024, option 1, to answer any questions.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Distributed Nationwide

Timeline

Recall initiated: 2016-12-12
Terminated: 2018-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151891. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.