Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
- Recall Initiated
- April 20, 2022
- Recall Number
- Z-1264-2022
- Quantity
- 4 units
- Firm Location
- Center Valley, PA
Reason for Recall
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.
Distribution
CA FL MA MD MI NJ OH PR WI
Lot / Code Info
UDI-DI: 04953170340833 Serial Number: 2836209F 2835978 2837272 2836299
Root Cause
Nonconforming Material/Component
Action Taken
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.