BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 3052070 · Received March 29, 2013

    Report

    Report Number
    3052070
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    January 31, 2012
    Report Date
    February 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE HANDPIECE REPEATEDLY ALARMED AND SAID TO CLEAN THE TIP. AFTER THE TIP WAS CLEANED THE DEVICE CONTINUED TO ALARM AND WOULD NOT WORK. A NEW HANDPIECE WAS USED TO CONTINUE THE SURGICAL PROCEDURE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPERATIVE PROCEDURE:TOTAL THYROIDECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129629 HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC * H44K9N

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR