BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON HARMONIC FOCUS

    MDR report key: 1911127 · Received November 29, 2010

    Report

    Report Number
    1911127
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE FAILED TO FIRE. UNKNOWN AT WHAT POINT DURING PROCEDURE THIS OCCURRED, BUT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON HARMONIC FOCUS INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ASCENT HEALTHCARE SOLUTIONS FCS9 1194205

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR