BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROWAND

    MDR report key: 1961460 · Received December 30, 2010

    Report

    Report Number
    1961460
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 22, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ARTHROCARE CORPORATION
    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

    DEVICE DID NOT WORK ONCE PLUGGED IN AS IT WOULD NOT ACTIVATE. DEVICE ALSO DID NOT WORK ON THE SECOND AND THIRD ATTEMPT. THERE WAS NO HARM TO THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DID NOT WORK WHEN PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROWAND RF WAND GEI ARTHROCARE CORPORATION SUPER TURBOVAC 90 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR