Device product
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Z-1891-2024
Product summary
- Firm
- Covidien, LP
- Event
- Event 94484
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1681 units
- Official record key
device-enforcement:Z-1891-2024
Official wording
Reason: Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Code information: GTIN: 10884521717633 20884521717630 Lot #: N3G1372Y
Distribution pattern: Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Derived failure modes
-
Unknown
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery