Device product
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Z-1438-2026
Product summary
- Event
- Event 98288
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-1438-2026
Official wording
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Code information: Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Complaints of the ceramic tip of the resection sheath breaking have been received.