BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821374 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00337
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 (B)(4) 2010 TO (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS AND IN THE OPEN CIRCUIT CONFIGURATION. THE REASON FOR RETURN COULD NOT BE CONFIRMED. THE GENERATOR DELIVERED COAG CORRECTLY INTO RATED LOADS AND IN THE OPEN CONFIGURATION. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COAGULATION FUNCTION WAS LOW AND SLOW. THERE WERE NO PT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE