—#193265

Product

Olympus Uretero-reno videoscope, Model No. URF-V2

FDA product code: NWB — Endoscope, Accessories, Narrow Band Spectrum
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K172246
Affected lot / code info: 1 unit, serial number 2825505F UDI 04953170343582

Why it was recalled

The bending section of the URF-V2 may crack, resulting in an abnormal shape or abnormal angulation of the bending section.

Root cause (FDA determination)

Process change control

Action the firm took

On March 25, 2022, the firm contacted the affected consignee to inform them that certain manufacturing changes by a supplier led to the possibility that a part within the bending section may crack. Olympus repaired the affected URF-V2 unit free of charge.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the state of AZ.

Timeline

Recall initiated: 2022-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.