BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821383 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00331
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    June 7, 2011
    Report Date
    June 8, 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 RECEIVED BY THE MFR FOR THE TIME PERIOD (B)(4) 2010 THROUGH (B)(4) 2012. THE PULSAR GENERATOR WAS RECEIVED IN FAIR CONDITION WITH MINOR SURFACE IMPERFECTIONS. THE UNIT DELIVERED RF ENERGY CORRECTLY INTO THE FIXED RESISTORS. THE FOOTSWITCH CORD-SET (CONNECTING FOOTSWITCH RECEIVER TO GENERATOR) HAD A BROKEN SHIELD DRAIN WIRE. HOWEVER, REPEATED FOOTSWITCH TESTING COULD NOT REPRODUCE THE COMPLAINT OF CUT FUNCTION CONTINUING AFTER PEDAL RELEASE. UNIT PERFORMED AS DESIGNED IN SERVICE. IT IS UNLIKELY THAT THE BROKEN SHIELD-DRAIN WIRE AFFECTED THE ABILITY OF THE UNIT TO STOP DELIVERING ENERGY. THE CORD-SET WAS REPLACED. 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 DOCTOR WAS USING THE FOOT PEDAL AND LET OFF THE PEDAL, BUT THE FUNCTION KEPT GOING. THE REPRESENTATIVE HAD TO DETACH THE WIRELESS ROUTER FROM THE CONSOLE TO GET IT TO STOP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PLASMABLADE