Device product
Octopus 4 Tissue Stabilizer, Model 29400
Z-2577-2026
Product summary
- Event
- Event 98966
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 590 units
- Official record key
device-enforcement:Z-2577-2026
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: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Manufacturing or process control
assembly issue