Device product
Octopus Evolution Tissue Stabilizer, Model TS2000
Z-2575-2026
Product summary
- Event
- Event 98966
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 134 units
- Official record key
device-enforcement:Z-2575-2026
Official wording
Reason: During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Code information: UDI-DI: 00643169668911; Serial Numbers: 0232992409 0233010063 0233010115
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Manufacturing or process control
assembly issue