BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR2

    MDR report key: 3002224 · Received March 13, 2013

    Report

    Report Number
    1226420-2013-00054
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    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: UNIT RECEIVED IN GOOD CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: 28 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION), 31 E5 (MONOPOLAR HANDPIECE HAS REACHED END OF LIFE), BOTH ERRORS ARE CONSIDERED NORMAL USE ERRORS. ROOT CAUSE: UNIT SENT BACK FOR YEARLY TECHNICAL AND SAFETY CHECK AND THERE WERE REPORTED CONCERNS ABOUT INSUFFICIENT POWER BEING DELIVERED WHICH COULD NOT BE REPLICATED IN THE SERVICE DEPARTMENT, CONCERNS ABOUT THE HANDPIECES NOT LOCKING INTO THE PLUG RECEPTACLE BUT THERE IS NO LOCKING MECHANISM, AND CONCERNS ABOUT THE NUMBER OF E3 ERRORS AND THE SYSTEM RELIABLY MEASURED PATIENT PAD IMPEDANCE WHILE DELIVERING ENERGY IN THE SERVICE DEPARTMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. EVAL CODE RESULTS: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. EVAL CODE CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. PRODUCT EVENT: (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

    PRODUCT'S COAGULATION AND CUTTING FUNCTIONS UNDERPERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105116 GENERATOR PULSAR2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1