Device product
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Z-2439-2012
Product summary
- Firm
- Covidien LP
- Event
- Event 63015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 135,712 units
- Official record key
device-enforcement:Z-2439-2012
Official wording
Reason: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Code information: All lot numbers
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.