PlainRecalls
FDA Devices Moderate Class II Terminated

EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D 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.

Reported: October 22, 2014 Initiated: September 17, 2014 #Z-0063-2015

Product Description

EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D 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.

Reason for Recall

Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
1,483 devices
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D 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.. Recalled by Intuitive Surgical, Inc.. Units affected: 1,483 devices.
Why was this product recalled? ▼
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2014. Severity: Moderate. Recall number: Z-0063-2015.

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