BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821357 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00346
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 3, 2011
    Report Date
    October 5, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION, WITH MINOR SURFACE IMPERFECTIONS. IN INITIAL TESTING, THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. A UCB SOFTWARE BUG WAS CONFIRMED. 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 THE MACHINE WAS NOT FUNCTIONING, THE COAGULATION CIRCUIT WORKS INTERMITTENTLY. MULTIPLE LOTS OF HANDPIECES WERE TRIED AND THEY COULD NOT GET THEM TO WORK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE