BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2822375 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00371
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    July 26, 2012
    Report Date
    July 26, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 08/15/2010 THROUGH 08/15/2012. EVAL: THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS DURING INITIAL TESTING. THE SERVICE DEPARTMENT WAS UNABLE TO REPLICATE THE COMPLAINT. 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 MID-PROCEDURE THERE WAS AN ERROR CODE THAT CAME UP (SCREEN TURNED ORANGE) AND IT SAID SOMETHING ABOUT A MODULAR HANDLE DISCONNECTION. THE HAND PIECE WAS NOT DISCONNECTED. THEY TURNED THE POWER CONSOLE OFF AND REBOOTED AND IT SEEMED TO WORK AFTER THAT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE 4.0, LOT 54190