BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1142-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1142-2015
    Event ID
    70467
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    February 11, 2015
    Classification Date
    February 24, 2015
    Termination Date
    June 1, 2015
    Address
    1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States

    Description

    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.

    Reason

    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.

    Code Info

    PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.

    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.

    Quantity

    3282 - total both part numbers