BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821445 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00305
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    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 MFR FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION WITH DARK AREAS ON THE UPPER LID AND LOWER CASE. THE BOTTOM NYLON SCREW HAD BEEN CLEAVED AND WAS MISSING. BOTH THE MONOPOLAR AN BIPOLAR CONNECTORS WERE STRIPPED AND DAMAGED. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE RF CONTROLLER SOFTWARE VERSION MAY NOT ALWAYS MEASURE THE IMPEDANCE OF A SPLIT FOIL PT RETURN PAD ACCURATELY WHEN ENERGY IS BEING DELIVERED. THE SOFTWARE WAS UPGRADED FOR THE RF CONTROLLER AND HAS THE FOLLOWING CHANGES: NO LONGER FLAGS E3 ERROR IS IMPEDANCE DROPS BELOW 15 OHM AND EVALUATES LAST 500 MS OF IMPEDANCE READINGS TO CALCULATE THE IMPEDANCE, RATHER THAN THE LAST 50 MS. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. APPLICABLE SOFTWARE AND HARDWARE UPGRADE WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED SOMETIMES DURING CUT AND COAG, THE SYSTEM STOPS FUNCTIONING. NO PROBLEM ON PTS.

    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