BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821289 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00377
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    May 31, 2012
    Report Date
    May 31, 2012
    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 MANUFACTURER FOR THE TIME PERIOD 08/15/2010 THROUGH 08/15/2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT GAVE AN E8 ERROR ON THE FIRST COAG. AFTER BEING POWERED UP. THIS IS A KNOWN ISSUE THAT WILL BE FIXED WITH UPGRADES. THE "COAG ISSUE" COULD NOT BE REPLICATED. THE UNIT DELIVERED RF ENERGY CORRECTLY ACROSS ALL MODES AND POWER LEVELS. 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 THE ERROR BOX KEPT POPPING UP ON THE PLASMABLADE GENERATOR WHEN THE SURGEON FIRST STARTED ACTIVATING THE HANDPIECE. IT SEEMED TO HAPPEN 3-4 TIMES BEFORE IT STOPPED. THE SURGEON ALSO COMMENTED THAT THE COAGULATION PROPERTIES IS NOT AS EFFECTIVE AS A BOVIE, EVEN AT A SETTING OF 9. THE BOX DISAPPEARED BEFORE THE CODE COULD BE READ. SECOND OF 3 EVENTS; SEE 3007069406-2012-00376 AND 3007069406-2012-00378.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE