BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR REFURB PULSAR2

    MDR report key: 3010785 · Received March 19, 2013

    Report

    Report Number
    1226420-2013-00073
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD, RESULTS, CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PLAN: UNIT RECEIVED IN FAIR CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. TO ENSURE CUT AND COAG ENERGY DELIVERY WAS NOT GOING INTO RF LEAKAGE TOO SOON THE FULL FINAL TEST (TP-0050) WAS PERFORMED. THE POWER MEASUREMENTS WERE WITHIN TOLERANCE THEREFORE THE COMPLAINT OF RF LEAKAGE COULD NOT BE CONFIRMED. (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 THE CASE THE GENERATOR ERRORED THAT IT WENT INTO RF LEAKAGE MITIGATION MODE AND THE SYSTEM THEN FAILED TO CUT OR COAGULATE TISSUE. THE GENERATOR WAS SWAPPED OUT AND THE CASE CONTINUED.

    Description of Event or Problem · 1

    GENERATOR WENT INTO RF LEAKAGE MITIGATION MODE AND SYSTEM FAILED TO CUT OR COAG TISSUE DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114691 GENERATOR REFURB PULSAR2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102RF

    Patients

    Seq Age Sex Outcome Treatment
    1