Device product
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Z-1063-2013
Product summary
- Firm
- Covidien LP
- Event
- Event 64420
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,751 units
- Official record key
device-enforcement:Z-1063-2013
Official wording
Reason: Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
Code information: Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
Distribution pattern: Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Derived failure modes
-
Unknown
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention