BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2841486 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00512
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    July 7, 2009
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED FOLLOWING A RETROSPECTIVE REVIEW OF COMPLAINTS. IT WAS REPORTED THAT THE PLASMABLADE TNA ARCED TO THE TONGUE DURING AN EVALUATION. INSPECTION OF THE LOT HISTORY RECORD FOR THIS LOT DID NOT NOTE ANY ISSUES DURING MANUFACTURING OF THIS LOT. THE FAILURE NOTED FOR THIS FAILURE MODE WAS A COMBINATION OF DESIGN AND USER TRAINING WHERE THE EXCHANGEABLE TIPS (TONSIL AND/OR ADENOID) MAY NOT BE FULLY INSERTED ON THE HANDPIECE DURING USE, WHICH COULD RESULT IN ARCING THROUGH THE EXPOSED CONDUCTIVE SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASMABLADE TNA ARCED TO THE TONGUE DURING AN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 11552

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR NOT AVAILABLE