Device product
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 86214
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 900,007 total
- Official record key
device-enforcement:Z-0003-2021
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: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X
Distribution pattern: Worldwide distribution - US Nationwide and Global Distribution.
Derived failure modes
-
Manufacturing or process control
assembly error