Device product
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0001-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 86214
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900,007 total
- Official record key
device-enforcement:Z-0001-2021
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: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X
Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.
Derived failure modes
-
Manufacturing or process control
assembly error