BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II REFURB GENERATOR

    MDR report key: 5004011 · Received August 14, 2015

    Report

    Report Number
    1226420-2015-00133
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 15, 2015
    Report Date
    October 16, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. - BARE METAL ON BOTH BOTTOM SIDES. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. - UNIT DELIVERED CORRECT RF ENERGY OUTPUT POWER IN BOTH CUT <(>&<)> COAG. ROOT CAUSE: PLASMABLADE IN QUESTION WAS NOT RECEIVED WITH THE UNIT, SO THERE WAS NO WAY OF VERIFYING CUSTOMER COMPLAINT. UNIT WAS EVALUATED <(>&<)> DELIVERED RF ENERGY OUTPUT WITHIN ACCEPTANCE RANGE IN ALL MODES. BARE METAL TO ENCLOSURE IS DUE TO ROUGH HANDLING OUT IN THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A PACEMAKER GENERATOR/COMPONENT EXCHANGE PROCEDURE, DR. LEE INDICATED THAT HE SAW A SPARK WHILE DISSECTING AROUND A LEAD ON COAG SETTING 5. THE REP WAS NOT AWARE OF THE DOCTOR TOUCHING THE LEAD AT ANY POINT DURING THE PROCEDURE. THE LEAD INSULATION WAS DAMAGED AND REQUIRED A NEW LEAD TO BE INSTALLED CAUSING A 15+ MINUTE DELAY. NO INJURY TO THE PATIENT WAS NOTED AND CASE WAS COMPLETED SUCCESSFULLY. PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED AS CUSTOMER CONTACT REFUSED TO PROVIDE REQUESTED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539893 PULSAR II REFURB GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102RF

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention