BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 4143115 · Received October 3, 2014

    Report

    Report Number
    4143115
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THE SONICISION DEVICE WOULD NOT COME ON AND DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618926 SONICISION INSTRUMENT, ULTRASONIC SURGICAL LFL COVIDIEN * 42392749X

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR