BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICISION

    MDR report key: 2953999 · Received January 15, 2013

    Report

    Report Number
    2953999
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY VALLEYLAB, A DIVISION ON TYCO HEALTHCARE
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    THE TIP BROKE OFF OF THE SONICISION DEVICE INSIDE THE PATIENT DURING USE. ANOTHER DEVICE WAS THEN USED AND THE SAME THING HAPPENED A SECOND TIME, THE TIP BROKE OFF. THE TIPS WERE REMOVED FROM THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPROSCOPIC ROUX-EN-Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21976 SONICISION INSTRUMENT,ULTRASONIC SURGICAL LFL COVIDIEN, FORMERLY VALLEYLAB, A DIVISION ON TYCO HEALTHCARE * 239712X

    Patients

    Seq Age Sex Outcome Treatment
    1 * LIKELY NO| POTENTIALLY OTHER LAPROSCOPIC INSTRUMENTS BUT MOST