BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822158 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00283
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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) 2010 THROUGH (B)(4) 2012. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS USING A PLASMABLADE 4.0 ACROSS ALL MODES AND POWER LEVELS. BOTH TNA HANDPIECES FUNCTIONED AND OUTPUT AS EXPECTED ACROSS ALL MODES AND POWER LEVELS. THE REASON FOR RETURN COULD NOT BE CONFIRMED. THE GENERATOR AND BOTH TNA DEVICES PERFORMED AS DESIGNED. THE E11 ERROR DOES NOT SUPPORT THE CLAIM THAT THE GENERATOR DOES NOT COAG. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO COAGULATION, ONLY THE CUT WORKED AT VERY HIGH TEMPERATURES. THE USER SWITCHED AND USED THE HANDPIECE WITH ANOTHER GENERATOR AND IT WORKED FINE. THE CONSOLE WAS USED TWICE AND THE COAGULATION OPTION WOULD NOT ENGAGE. THERE WAS NO PT INJURY.

    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 TNA X2 (B)(4)