BEUDAMED
    FDA Adverse Event Summary report: N

    MARILYN INSTRUMENT

    MDR report key: 3904693 · Received May 29, 2014

    Report

    Report Number
    3904693
    Date Received
    May 29, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A POTENTIAL HUMAN FACTORS ISSUE, THE INSTRUMENT WAS PLUGGED INTO A MONOPOLAR SPOT AND NOT THE CORRECT BIPOLAR SPOT. THE MARILYN INSTRUMENT WOULD NOT SHUT OFF UNTIL UNPLUGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317356 MARILYN INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INTUITIVE SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR DAVINCI