BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II REFURB

    MDR report key: 5067526 · Received September 10, 2015

    Report

    Report Number
    1226420-2015-00151
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    June 4, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4). EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT IS IN GOOD CONDITION. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. -USED SERVICE DEPARTMENT MONOPOLAR 7 PATIENT RETURN RECEPTACLES TO TEST UNIT <(><<)>(><(>&<)><(><<)>)> THERE WERE NO PERFORMANCES ISSUES FOUND. DELIVERED RF ENERGY PROPERLY IN ALL MODES. UNIT WAS POWERED UPON AT LEAST 14 DAYS IN THE FIELD. ERROR LOG CONTAINS 35 E3S (PATIENT RETURN ELECTRODE HAS POOR CONNECTION.) ALL ERROR LOG ENTRIES ARE CONSIDERED ¿NORMAL USE¿ ERRORS AND ARE NOT INDICATIVE OF A PROBLEM WITH THE UNIT. UNIT FAILED ELECTRICAL SAFETY TEST (TP-314-002911-3) STEP 7.2.9.A/B MONOPOLAR PATIENT CONNECTOR TO MAINS (4000VAC). AUDIBLE ARCING FROM WITHIN UNIT. ROOT CAUSE: MONOPOLAR RECEPTACLE CONNECTOR HAS INSULATION INCORRECTLY CRIMPED TO PIN 4 (CUT OUT) <(><<)>(><(>&<)><(><<)>)> DURING DISASSEMBLY PATIENT RETURN RECEPTACLE ONE OF THE WIRES WAS BROKEN OFF, BUT LOOSELY HELD IN POSITION AGAINST RECEPTACLE BY THE RF AMP CAUSING THE ERROR CODE¿REPLACING THE RECEPTACLE WILL CORRECT ISSUE. AFTER REWORK <(><<)>(><(>&<)><(><<)>)> DURING TESTING PROCEDURES THE UNIT FAILED ELECTRICAL SAFETY TESTING (TP-314-002911-3) WITH AUDIBLE INTERNAL ARCING <(><<)>(><(>&<)><(><<)>)> TRIPPED FAILED INDICATORS ON TEST EQUIPMENT¿RF AMP NEEDS TO BE REPLACED, BECAUSE READINGS ARE HIGH. (B)(4).

    Description of Event or Problem · 1

    DURING SERVICING FOR AN UNRELATED ISSUE THE GENERATOR FAILED FINAL ELECTRICAL TESTING DUE TO A COMPONENT FAILURE THAT RESULTED IN ARCING WITHIN THE GENERATOR. NO PATIENT INVOLVEMENT THEREFORE PATIENT INFORMATION NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599569 GENERATOR PULSAR II REFURB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102RF

    Patients

    Seq Age Sex Outcome Treatment
    1