BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 2846248 · Received November 27, 2012

    Report

    Report Number
    1226420-2012-00078
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 31, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. TO CHECK FOR POSSIBLE RF LEAKAGE ISSUE STEPS 5.9 AND 5.11 OF THE FINAL TEST (TP-0050) WERE PERFORMED. THE POWER MEASUREMENTS SHOWED THE UNIT CORRECTLY DELIVERING POWER TO RATED LOADS. HOWEVER, IN OPEN-CIRCUIT CONFIGURATION (WHICH REPRESENT THE HANDPIECE NOT IN CONTACT WITH THE PATIENT), THE OUTPUT WAS FOUND TO FLUCTUATE BETWEEN LOW POWER RF LEAKAGE MODE AND NORMAL POWER. THIS WAS FOUND TO BE DUE TO INCORRECT WIRING FOR THE SINGLE CURRENT SENSE TRANSFORMER (T9) ON THE RF BOARD, IT WAS FOUND TO BE BACKWARDS AND WAS CORRECTED. AFTER T9 WIRING CORRECTED THE UNIT RELIABLY WENT INTO RF LEAKAGE MODE DURING THAT PART OF THE TEST. ERROR LOG: 4 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION), 1 E5 (MONOPOLAR HANDPIECE HAS REACHED END OF LIFE), 21 E7 OR E8 (VOLTAGE INTERLOCK ERROR, GENERATOR OVERCURRENT). ERRORS ARE NORMAL USE ERRORS BUT TO ADDRESS OCCURRENCE OF E7 AND E8 470UF CAPACITORS ON DC POWER SUPPLY PCBA WILL BE REPLACED. ROOT CAUSE: THE WEAK POWER OUTPUT COMPLAINT COULD NOT BE REPRODUCED AND THE UNIT WAS FOUND TO DELIVER RATED POWER TO RATED LOADS DURING POWER OUTPUT TESTING. HOWEVER, DURING TEST CASE OF OPEN CIRCUT CONFIURATION THE UNIT WAS FOUND TO EXPERIENCE DIFFICULTY STAYING IN THE REDUCED POWER RF LEAKAGE MODE DUE TO INCORRECT WIRING OF T9 ON RF BOARD. NOTE: PRIOR TO ORIGINAL SHIPMENT THE UNIT IS DOCUMENTED AS HAVING CORRECTLY GONE INTO RF LEAKAGE MODE DURING FINAL TEST. (B)(4).

    Description of Event or Problem · 1

    WEAK POWER OUTPUT OF GENERATOR AND DEVICE.

    Description of Event or Problem · 1

    WEAK POWER OUTPUT OF GENERATOR AND DEVICE.

    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