BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI

    MDR report key: 2850166 · Received November 21, 2012

    Report

    Report Number
    3006524618-2012-00913
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLANTAR FASCIITIS PROCEDURE USING A TOPAZ IFS WAND, THE WAND SPARKED AND MADE AN UNCHARACTERISTIC NOISE, THEN STOPPED WORKING. THE PROCEDURE WAS COMPLETED BY OPTING TO DO A SURGICAL RELEASE ON THE PT. THERE WAS NO SIGNIFICANT DELAYS OR PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ MICRODEBRIDER WITH INTEGRATED FINGER SWI ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION AT20820-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other