Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Recall
- Recall Number
- Z-0908-2018
- Event Number
- 79166
- Firm
- Covidien LLC
- FEI Number
- 1219930
- Product Code
- GDW
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 15, 2017
- Terminated
- December 19, 2018
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908
Description
Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, e.g. low anterior resection. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The device cartridge disengaged during use due to manufacturing error.
Medtronic sent an "URGENT MEDICAL RECALL LETTER" dated September 13, 2017, was issued to customers titled "Covidien Endo GIA Black Radial Reload with Tri-Staple Technology" urging customers to quarantine and return unused product to recalling firm. Questions or concerns can be directed to: [email protected]. For further questions, please call (203) 492-5000.
Internationally, including Japan. No USA Customers
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