BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE SPORTS MEDICINE RF WAND

    MDR report key: 1920184 · Received November 15, 2010

    Report

    Report Number
    1920184
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRODUCT STOPPED CAUTERIZING AND SUCTIONING.======================HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE FAILURE EXTENDED ANESTHESIA TIME.======================MANUFACTURER RESPONSE FOR ARTHROCARE CAUTERIZER, ARTHOCARE WAND======================TOOK INFORMATION ABOUT PRODUCT AND WILL RETURN ONCE WE RECEIVE LETTER THAT ASCENT WILL BE TAKING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE SPORTS MEDICINE RF WAND ARTHROCARE CAUTERIZER GEI ASCENT HEALTHCARE SOLUTIONS * 1309256

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR