Device product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Z-1851-2026
Product summary
- Event
- Event 98550
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 830 units
- Official record key
device-enforcement:Z-1851-2026
Official wording
Reason: Potential for detachment of a distal tip component of the device during use.
Code information: Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers.
Distribution pattern: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Derived failure modes
-
Unknown
Potential for detachment of a distal tip component of the device during use.