BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PLASMABLADE

    MDR report key: 2822412 · Received October 23, 2012

    Report

    Report Number
    2822412
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ONCE CONNECTED TO THE PLASMA GENERATOR THE PEAK PLASMA BLADE DID NOT DELIVER ENERGY. THE PLASMA GENERATOR SCREEN FROZE AND ADJUSTMENTS COULD NOT BE MADE TO CUT OR COAG. THE PLASMA BLADE WAS AT THAT TIME REMOVED FROM THE GENERATOR AND THE GENERATOR APPEARED TO RESET. THE SAME PLASMA KNIFE WAS THEN REINSERTED INTO THE GENERATOR AND THE SAME THING HAPPENED. AT THAT TIME A NEW PLASMA BLADE WAS OPENED AND PLUGGED INTO THE GENERATOR. THERE WERE NO ISSUES WITH THE SECOND PLASMA BLADE.MANUFACTURER TOLD THE FACILITY THAT THEY WOULD LOOK AT THE DEVICE AND TRY TO DETERMINE IF THERE WERE ANY MANUFACTURING ISSUES. THE REPRESENTATIVE STATED THAT A REPORT WOULD FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK PLASMABLADE ELECTROSURGICAL UNIT GEI MEDTRONIC ADVANCED ENERGY PS200-040 55016

    Patients

    Seq Age Sex Outcome Treatment
    1 *