Device product
Model No. CYF-5, Cystonephrofiberscope
Z-0684-2024
Product summary
- Event
- Event 93583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3457 US; 8122 Global
- Official record key
device-enforcement:Z-0684-2024
Official wording
Reason: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Code information: UDI-DI: 04953170292323 04953170339417 04953170411144 All serial numbers
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.