BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ MICRODEBRIDER WITH INTEGRATED CABLE

    MDR report key: 4202592 · Received September 18, 2014

    Report

    Report Number
    3006524618-2014-00292
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ARTHROCARE CORP
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING A TOPAZ MICRODEBRIDER ICW WAND, THE WAND WAS WORKING ONLY INTERMITTENTLY. THE PROCEDURE WAS STOPPED AND RESCHEDULED FOR ANOTHER DAY, AS NO BACKUP DEVICE WAS AVAILABLE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580915 TOPAZ MICRODEBRIDER WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORP 1048722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other