—#151898

Product

Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney.

FDA product code: NWB — Endoscope, Accessories, Narrow Band Spectrum
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K072957
Affected lot / code info: All serial numbers

Why it was recalled

Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue trauma, including perforation, and insertion tubes which were stuck inside the patient and had to be surgically removed.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm, Olympus, sent an "Urgent Medical Device Safety Notice" on December 29, 2016, to those that were affected by this issue. The letter addressed the corrective actions Olympus were taking 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 and complete and return the OLYMPUS URGENT MEDICAL DEVICE SAFETY NOTIFICATION via fax to: Olympus Regulatory Affairs Department at 484-896-7128.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution-US Nationwide and country of: Canada.

Timeline

Recall initiated: 2016-12-12
Terminated: 2018-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151898. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.