FDA-Device2015-03-04Class II
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Intuitive Surgical, Inc.
Hazard
Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected count
3282 - total both part numbers
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1142-2015Don't want to check this manually?
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