Device product
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Z-1372-2026
Product summary
- Event
- Event 98188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88,268 units
- Official record key
device-enforcement:Z-1372-2026
Official wording
Reason: Firm is initiating a removal due to continued reports of adverse events.
Code information: Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; 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.