BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR

    MDR report key: 2821461 · Received October 25, 2012

    Report

    Report Number
    3007069406-2012-00302
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    February 14, 2011
    Report Date
    February 14, 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 POOR CONDITION WITH SCRATCHES ON THE UPPER LID, THE FRONT PANEL WAS SCUFFED AND SCRATCHED. THE 9 E7 ERRORS THAT OCCURRED ON THE LAST DAY OF USE WERE CAUSED BY THE VOLTAGE TO THE WIRE CHIP ONLY REACHING 0.9 VOLTS. THE UNIT WAS ALREADY EQUIPPED WITH A CAPACITIVE CABLE HARNESS TO SHUNT NOISE TO THE EARTH GROUND. ADD'L DATA INTEGRITY WAS ACHIEVED BY INCREASING THE VALUES OF THE PULL-UP RESISTORS USED BY THE OPTOCOUPLERS, ALLOWING THE LOW VALUES TO FALL LESS THAN THE BORDERLINE VALUE OF 0.8 VOLTS. 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 TOTAL KNEE REPLACEMENT SURGERY, WHILE PROGRESSING TO THE POSTERIOR PART OF THE KNEE, THE POWER OUTPUT CEASED ABRUPTLY. THE HAND PIECE WAS STILL RECOGNIZED BY THE GENERATOR AND STILL REGISTERING CUT AND COAG MODE, ETC. THERE WAS NO POWER OUTPUT AT THE END OF THE PLUS LIP THAT WAS WORKING FINE SECONDS PRIOR.

    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