Device product
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0636-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79169
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,816
- Official record key
device-enforcement:Z-0636-2018
Official wording
Reason: Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Code information: N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
Distribution pattern: Nationally
Derived failure modes
-
Unknown
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.