BEUDAMED
    FDA Enforcement 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

    Recall: Z-1141-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1141-2015
    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, 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

    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 410322-05Serial numbers: M10140807 M10140926 M10141028 M10141119 M11140917 M11141119 M10140812 M10141001 M10141029 M10141125 M11140922 M11141125 M10140814 M10141004 M10141031 M10141126 M11140926 M11141126 M10140818 M10141006 M10141104 M10141128 M11141001 M11141201 M10140826 M10141009 M10141105 M10141201 M11141004 M10140828 M10141015 M10141107 M11140808 M11141006 M10140902 M10141020 M10141111 M11140818 M11141009 M10140905 M10141022 M10141113 M11140826 M11141015 M10140917 M10141023 M10141114 M11140828 M11141020 M10140922 M10141024 M10141117 M11140904 M11141024

    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 units, all part numbers