Device product
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Z-1376-2026
Product summary
- Event
- Event 98188
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 units
- Official record key
device-enforcement:Z-1376-2026
Official wording
Reason: Firm is initiating a removal due to continued reports of adverse events.
Code information: Lot Code: Model: TB-0520FC; UDI: 04953170370519, 04953170370502; 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.