BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822366 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00197
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. VISUAL INSPECTION OF THE TWO RETURNED PLASMABLADE EXT DID NOT EXHIBIT ANY ANOMALIES. FUNCTIONAL TESTING DID NOT CONFIRM THE FAILURE REPORTED. BOTH CUT/COAG BUTTONS WERE FULLY FUNCTIONAL. THE EVENT REPORTED WAS NOT CONFIRMED. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL HIP REPLACEMENT, THE PEAK EXT HANDPIECE WAS NOT GIVING POWER IN THE COAG MODE. COAG WAS SET AT 10 AND WHEN HE TRIED TO USE IT, IT ONLY GAVE A QUICK "BLIP" AND THEN NOTHING. THEY TRIED ANOTHER EXT HANDPIECE AND THE SAME EXACT ISSUE OCCURRED. THE OTHER MACHINE WAS BROUGHT IN AND WE PLUGGED IN THE SECOND HANDPIECE THAT WAS OPENED, BUT THE MACHINE READ "HANDPIECE PAST PRIME" AND THE MACHINE DIDN'T FUNCTION. AT THIS POINT THE SURGEON WAS FRUSTRATED AND OPTED TO JUST USE THE BOVIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE EXT 31469

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR