BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II REFURB

    MDR report key: 3951124 · Received July 22, 2014

    Report

    Report Number
    1226420-2014-00054
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). METHOD, RESULTS, CONCLUSION: FACILITY NOT RETURNING PRODUCT. (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 A CASE THE SURGEON GOT TOO CLOSE TO SKIN EDGE DURING THE GRACILIS FLAP DISSECTION AND BURNED THE FLAP BEING EXCISED FROM THE INSIDE OUT. THE BURN WAS ABOUT 5MM X 5MM IN SIZE. THE SECTION OF THE FLAP THAT WAS BURNED WAS EXCISED AND THE REMAINDER OF THE FLAP UTILIZED. NO PATIENT IMPACT NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427694 GENERATOR PULSAR II REFURB GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102RF

    Patients

    Seq Age Sex Outcome Treatment
    1