Recall Z-0685-2024 ยท FAJ Cystoscope And Accessories, Flexible/Rigid
Shirakawa Olympus Co., Ltd.
Model No. CYF-5R, Cystonephrofiberscope
| Date | Jan 9, 2024 (initiated Dec 4, 2023) |
| Status | Open, Classified |
| Reason | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. |
| Root cause | Under Investigation by firm |
| Action | On December 4, 2023, the firm notified customers of the recall via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed of the updates to the instructions for use (IFU). Customers were instructed to ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions. Please locate and replace any on-hand copies of the IFU with the updated version. The most current version of the Instructions for Use can be obtained from the Olympus Connect customer web portal at https://www.OlympusConnect.com. New users will need to register. |
| Quantity | 2551 US; 3738 Global |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221690 | OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) Olympus Medical Systems Corp., Dec 29, 2022 |