—#193724

Product

Olympus URETERO-RENO FIBERSCOPE Model: URF-P6

FDA product code: FGB — Ureteroscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K172298
Affected lot / code info: UDI-DI: 04953170340802 Serial Number: 2836210 2834747I

Why it was recalled

Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated. 2. An Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. 3. Olympus will arrange for a service loaner in an effort not to disrupt clinical care. Contact me directly at 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.

Recalling firm

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

Distribution

Distribution pattern: CA FL MA MD MI NJ OH PR WI

Timeline

Recall initiated: 2022-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.