BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELLEVE HANDPIECE

    MDR report key: 2506033 · Received March 22, 2012

    Report

    Report Number
    2428235-2012-00002
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K082834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE BEING PUT INTO SERVICE IN MAY, 2011, THE HANDPIECE WAS USED ON 5-10 PTS PER WEEK, BY UTILIZING THE FINGERSWITCH TO ACTIVATE IT. APPROXIMATELY A WEEK PRIOR TO THE REPORTED PROBLEM, THE HANDPIECE STOPPED WORKING (AT BEST SOME INTERMITTENT ACTIVITY) WHEN ACTIVATED WITH THE FINGERSWITCH. INSTRUCTIONS FOR USE STATE: "IMMEDIATELY REPLACE ANY PRODUCT WHICH WAS VISIBLE DAMAGE OR IS NOT FUNCTIONING PROPERLY". RATHER THAN STOPPING THE USE OF THE PRODUCE ONCE THE FINGERSWITCH ACTIVATION FAILED, SHE BEGAN USING THE HANDPIECE BY ACTIVATING IT WITH THE FOOTPEDAL.

    Description of Event or Problem · 1

    NEAR THE END OF A 45 MINUTE PROCEDURE, THE AESTHETICIAN HEARD A POPPING SOUND WITH HER 15MM HANDPIECE. AT THE CONNECTION BETWEEN THE CABLE AND THE HANDPIECE, SHE SAW SPARKS AND 3 FLAMES SHOOT OUT OF THE CABLE. THE CABLE SEPARATED FORM THE HANDPIECE. SHE RELEASED THE FOOTPEDAL. THE SPARKING AND FLAMES STOPPED IMMEDIATELY. NEITHER THE PT NOR THE USER WAS INJURED. THE PT WAS NOT AWARE OF THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELLEVE HANDPIECE G E I GEI ELLMAN INTERNATIONAL, INC. D115FSHP 36819

    Patients

    Seq Age Sex Outcome Treatment
    1