Device product
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Z-1441-2026
Product summary
- Event
- Event 98288
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,484 units
- Official record key
device-enforcement:Z-1441-2026
Official wording
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Code information: Model No. Model No. A22041A; UDI: 04042761020961; All Lots.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Complaints of the ceramic tip of the resection sheath breaking have been received.