BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEW LIGASURE 5MM

    MDR report key: 3550261 · Received November 7, 2013

    Report

    Report Number
    1717344-2013-00928
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    October 7, 2013
    Report Date
    October 13, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PIECE OF THE JAW DETACHED WHEN THE SURGEON TRIED TO CLOSE THE JAWS. THE MATERIAL WAS REMOVED FROM THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576900 MEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 247763X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK