BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2822369 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00198
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 6, 2010
    Report Date
    October 6, 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 08/15/2010 THROUGH 08/15/2012. VISUAL INSPECTION OF THE TWO RETURNED PLASMABLADE NEEDLES REVEALED NO ANOMALIES. DURING FUNCTIONAL TESTING BOTH COAG AND CUT BUTTONS WERE FULLY FUNCTIONAL. REVIEW OF THE LOT HISTORY REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO THE PROCEDURE THE GENERATOR AND HANDPIECE WERE SET UP SUCCESSFULLY. IT WORKED FOR ABOUT 5 MINUTES AND THEN JUST STOPPED WORKING. THE LIGHTS AND SIGNS WERE OK, BUT THERE WAS NO ENERGY TO THE TIP. THE CUT AND COAG HAD BEEN SET AT 4/4. THE "IN USE" SOUND WAS STILL WORKING. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE NEEDLE 30544

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR