BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821352 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00349
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Report Date
    November 8, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION, WITH MINOR SURFACE IMPERFECTIONS. A SOFTWARE BUG IN THE VERSION WAS CONFIRMED. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE UNIT WAS REPAIRED. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE THE SURGEON WAS USING THE FINGER CONTROL (SETTINGS ALWAYS AT 4 AND 6 COAG ONLY), THE WARNING LIGHT THAT THE BOVINE PAD IS NOT MAKING A CONNECTION PROPERLY, KEEPS FLASHING ORANGE. THE BOVIE PAD WAS SWITCHED OUT AND THE PROBLEM CONTINUED. THEY HAD ABOUT 4 CASES WITH IT WHERE IT WORKED FINE, BUT THEN HALF WAY THROUGH THE CASE IT FLASHES THE WARNING INTERMITTENTLY THROUGH THE REST OF THE CASE. NO IMPACT ON ANY OF THE PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI