BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3252619 · Received July 15, 2013

    Report

    Report Number
    1717344-2013-00509
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 THE JAWS OF THE DEVICE WOULD NO LONGER OPEN WHILE ON TISSUE. THE SURGEON USED SCISSORS TO CUT THE TISSUE ADJACENT TO THE JAWS IN ORDER TO REMOVE THE DEVICE. THE PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLOOD LOSS AND NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327570 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 247544X

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR