Device product
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Z-1371-2026
Product summary
- Event
- Event 98188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 9,542 units
- Official record key
device-enforcement:Z-1371-2026
Official wording
Reason: Firm is initiating a removal due to continued reports of adverse events.
Code information: Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Derived failure modes
-
Unknown
Firm is initiating a removal due to continued reports of adverse events.