Recall Z-1262-2022 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5
| Date | Apr 20, 2022 |
| Status | Open, Classified |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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, |
| Quantity | 7 units |
| Distribution | CA FL MA MD MI NJ OH PR WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT The Olympus Optical Co., Mar 30, 2000 |