BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2831417 · Received November 14, 2012

    Report

    Report Number
    1226420-2012-00071
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 25, 2012
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: 6 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION) AND E3 IS A NORMAL USE ERROR. TO ENSURE CUT AND COAG ENERGY DELIVERY WAS NOT WEAK STEPS 5.6 AND 5.12 OF THE FINAL TEST (TP-0050) WERE PERFORMED AND THE POWER MEASUREMENTS WERE WITHIN TOLERANCE THEREFORE, THE REPORTED INCIDENT COULD NOT BE CONFIRMED. ROOT CAUSE: THE UNIT DID NOT EXHIBIT LOW OUTPUT POWER IN THE SERVICE DEPARTMENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WEAK COAG WHEN USING PULSAR II GENERATOR.

    Description of Event or Problem · 1

    WEAK COAG WHEN USING PULSAR II GENERATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1