BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821426 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00071
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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 REC'D BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS REC'D IN FAIR CONDITION WITH DARK SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THERE WAS ONE OCCURRENCE OF AN F6 FAULT IN THE ERROR LOG FILE. THE HARNESS BETWEEN THE RF CONTROLLER AND UCB WAS DRAPED NEAR THE CUT/COAG HIGH FREQUENCY POWER TRANSISTORS. RE-POSITIONING THE HARNESS REDUCED THE AMOUNT OF NOISE THAT THE COMMUNICATION WIRES ARE EXPOSED TO AND HELP REDUCE THE OCCURRENCES OF F6 FAULTS. 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 DURING A CASE, THE F6 (RF MODULE COMMUNICATION WITH THE CONTROLLER PROCESSOR HAS FAILED) FAULT APPEARED. THEY REBOOTED AND CONTINUED THE CASE.

    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