PlainRecalls
FDA Devices Moderate Class II Terminated

EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05

Reported: March 4, 2015 Initiated: February 11, 2015 #Z-1141-2015

Product Description

EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05

Reason for Recall

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
3282 total units, all part numbers
Distribution
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.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05. Recalled by Intuitive Surgical, Inc.. Units affected: 3282 total units, all part numbers.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2015. Severity: Moderate. Recall number: Z-1141-2015.

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