BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822169 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00271
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    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 THROUGH (B)(4) 2012. EVAL: THE PULSAR GENERATOR WAS RECEIVED IN POOR CONDITION, THE UPPER LID WAS DENTED AND DISCOLORED. POWERED ON UNIT AND LCD VGA DISPLAY HAD NO TEXT. THE BACKLIGHT WAS FUNCTIONING NORMALLY. FOUND THAT THE LCD VIDEO DATA CABLE SHIELDED HARNESS CONNECTOR HAD BECOME UN-SEATED FROM THE UCB PCBA RECEPTACLE. RE-SEATING CONNECTOR RESTORED NORMAL LCD DISPLAY FUNCTION. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. THE SHIELDED VIDEO CABLE CONNECTOR APPEARED TO BE ENGAGED BUT WAS NOT FULLY SEATED ON THE UCB RECEPTACLE. MAY HAVE BEEN CONNECTED MARGINALLY DURING MFR OR CONNECTION INSPECTION. APPLICABLE SOFTWARE AND HARDWARE UPGRADES WERE PERFORMED. THE UNIT PASSED FINAL TESTING AND WAS RECERTIFIED FOR USE. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A MASTECTOMY PROCEDURE, THE COAG FUNCTION JUST STOPPED. THERE WERE NO CODES DISPLAYED. THE CASE WAS COMPLETED WITH A BOVIE. THERE WAS NO PT HARM.

    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