Device product
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Z-0908-2018
Product summary
- Firm
- Covidien LLC
- Event
- Event 79166
- Status
- Terminated
- Classification
- Class II
- Quantity
- 163
- Official record key
device-enforcement:Z-0908-2018
Official wording
Reason: The device cartridge disengaged during use due to manufacturing error.
Code information: Product number: EGIARADXT Lot code: N6L0351X
Distribution pattern: Internationally, including Japan. No USA Customers
Derived failure modes
-
Manufacturing or process control
manufacturing error