BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822135 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00287
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT POWERED ON BUT DID NOT OUTPUT ENERGY FROM THE HAND PIECE ALTHOUGH VISUALLY THE UNIT INDICATED NORMAL OUTPUT. THE U9 OCTOCOUPLER WAS FOUND TO HAVE HAD AN OPEN LED INTERNALLY. WHEN THE U9 WAS REPLACED, THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS ACROSS ALL MODES AND OUTPUT LEVELS. FOR REASONS UNK, THE INTERNAL LED OF THE OCTOCOUPLER U9 FAILED IN THE OPEN CONDITION WHICH PREVENTED THE GENERATOR'S OUTPUT DRIVE CIRCUITS FROM BEING ENABLED. NO RF OUTPUT ENERGY WAS THE RESULT UNCLEAR HOW THE U9 COMPONENT FAILED SINCE THE GENERATOR UNDERGOES ACTIVE AND PASSIVE BURN-IN TESTING PRIOR TO SHIPMENT. REPAIRS WERE PERFORMED AND THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT WAS REPAIRED AND PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE, THE GENERATOR WORKED FOR 90 MINUTES, AFTER THAT IT STOPPED FOR 30 MINUTES AND DIDN'T WORK ANYMORE. THERE WAS NO ENERGY TO THE PLASMABLADE. VALLEYLAB DISPOSABLE PADS WERE BEING USED. THEY ATTEMPTED TO REPLACE WITH A NEW BLADE, BUT NOTHING HAPPENED, THEY CHANGED THE DISPOSABLE PADS WITH ANOTHER TYPE, HAD THE SAME PROBLEMS WITH MONOPART AND BIPART PADS, THEY SWITCHED OFF ALL OTHER ELECTRO MEDICAL DEVICES IN THE ROOM. THE ORANGE INDICATOR SHOWED 2 BARS AND DIDN'T WORK.

    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