FDA-Device2018-03-14Class II
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 p
Covidien LLC
Hazard
The device cartridge disengaged during use due to manufacturing error.
Sold states
Internationally, including Japan. No USA Customers
Affected count
163
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0908-2018Don't want to check this manually?
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