BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH GRIP ASSIST

    MDR report key: 3896460 · Received June 2, 2014

    Report

    Report Number
    3896460
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING NECK DISSECTION, HARMONIC DEVICE WAS FUNCTIONING FINE UNTIL CUTTING FUNCTION WOULD NO LONGER OPERATE. THE COAGULATION FUNCTION WAS STILL OPERATING. THE DEVICE WAS TAKEN OFF THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322575 ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH GRIP ASSIST INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER SUSTAINABILITY SOLUTIONS * 2919480

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR