BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS CURVED SHEARS

    MDR report key: 3901547 · Received June 18, 2014

    Report

    Report Number
    3901547
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    HARMONIC PASSED START-UP TEST BUT FAILED TO FIRE WHEN IN USE ON THE PATIENT. IT WAS DISCONNECTED AND RECONNECTED, PASSED THE QA TESTING AGAIN, BUT FAILED TO FIRE WHEN IN USE. A NEW HANDPIECE WAS THEN OPENED AND WORKED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358062 HARMONIC FOCUS CURVED SHEARS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC FCS9 L4E75A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR