BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822270 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00253
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS REC'D BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. EVAL: THE UNIT REC'D IN FAIR CONDITION. A POWER CORD AND A USER MANUAL WERE REC'D. THE UNIT DELIVERED PEAK CUT ENERGY BUT COULD NOT OUTPUT ANY CUT OR COAG ENERGY. TROUBLE-SHOOTING REVEALED THAT THE U4 OPTOCOUPLER (ON THE DC POWER SUPPLY) WAS NOT FUNCTIONAL. WHEN U4 WAS REPLACED, THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. THE LED SIDE MEASURES OPEN CIRCUIT WHICH ACCOUNTS FOR THE NON-FUNCTIONING POWER SUPPLY. IT IS UNK WHY THIS EARLY FAILURE OCCURRED. APPLICABLE HARDWARE AND SOFTWARE UPGRADES WERE PERFORMED. THE U4 WAS REPLACED. ALL SAFETY AND FINAL TESTS WERE PERFORMED AND THE UNIT WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE BEGINNING OF A CASE, THE GENERATOR WAS SET UP AND THE PT WAS GROUNDED. EVERY TIME THE COAG BUTTON WAS PRESSED, AN F9 ERROR CODE APPEARED (POWER SUPPLY UNDERCURRENT). THE SURGEON SWITCHED TO A TRADITIONAL BOVIE FOR THE CASE. A SURGE PROTECTOR WAS USED AND THERE WERE NO OTHER ELECTROSURGICAL DEVICES IN CLOSE PROXIMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR GENERATOR GEI MEDTRONIC ADVANCED ENERGY LLC PULSAR GENERATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE