BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEP

    MDR report key: 3915222 · Received July 2, 2014

    Report

    Report Number
    3915222
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 25, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    BIPOLAR NOT CAUTERIZING WHEN ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385544 FENESTRATED BIPOLAR FORCEP SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE SURGICAL, INC. 428093 S10140311

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR