BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS

    MDR report key: 3983007 · Received July 18, 2014

    Report

    Report Number
    3983007
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIGASURE INSTRUMENT WAS NOTED TO HAVE A WIRE POKING OUT OF THE WORKING TIP. UNSURE IF WIRE WAS THERE FROM THE BEGINNING OF THE CASE. ONCE IT WAS NOTICED, IT WAS TAKEN OUT OF SERVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423549 LIGASURE ATLAS ELECTROSURGICAL, CUTTING, COAGULATION GEI COVIDIEN * S4D0011X

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR