BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ MICRODEBRIDER WITH FINGER SWITCH

    MDR report key: 3112099 · Received May 7, 2013

    Report

    Report Number
    3006524618-2013-00171
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K080282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR PROCEDURE USING A TOPAZ MICRODEBRIDER IFS WAND, THE WAND STOPPED WORKING AND THE TIP ALLEGEDLY EXPLODED. THE PROCEDURE WAS ABLE TO BE COMPLETED USING A BACK UP WAND WITHOUT SIGNIFICANT DELAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199926 TOPAZ MICRODEBRIDER WITH FINGER SWITCH ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION AT24220-A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other