Device product
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Z-2576-2026
Product summary
- Event
- Event 98966
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 288 units
- Official record key
device-enforcement:Z-2576-2026
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: 00643169668904, 00613994764379; Serial Numbers: 0232670681 0232709164 0232709168 0232709194 0232709194 0232709199
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Manufacturing or process control
assembly issue