BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC

    MDR report key: 2802710 · Received September 12, 2012

    Report

    Report Number
    2802710
    Event Type
    Malfunction
    Date Received
    September 12, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 12, 2012
    Manufacturer
    ARTHROCARE CORPORATE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARTHROWAND NOTED TO HAVE "ERROR IN WAND" WHEN PLUGGED INTO THE GENERATOR. A NEW ARTHROWAND WAS UTILIZED AND WORKED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIENT SUPER TURBOVAC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATE * 0115120-13

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR