Device product
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0009-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 86214
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900,007 total
- Official record key
device-enforcement:Z-0009-2021
Official wording
Reason: The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
Code information: Lot Numbers: 00Z2117
Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.
Derived failure modes
-
Manufacturing or process control
assembly error