Device product
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Z-1830-2019
Product summary
- Firm
- Covidien LLC
- Event
- Event 82950
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,113,280
- Official record key
device-enforcement:Z-1830-2019
Official wording
Reason: The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
Code information: N8L0311KY N8M0063KY
Distribution pattern: Nationwide domestic distribution, worldwide foreign distribution.
Derived failure modes
-
Unknown
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.