BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 3061786 · Received March 29, 2013

    Report

    Report Number
    1717344-2013-00235
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED FOR EVAL. THE JAWS WERE NOT STUCK SHUT. THE HANDLE WAS LATCHED AND UNLATCHED TEN TIMES WITH NO PROBLEM. WE COULD NOT CONFIRM THE CUSTOMER'S REPORT OF THE JAWS NOT BEING ABLE TO OPEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NO LONGER OPEN WHILE ON TISSUE. THE DEVICE WAS OPENED WITH MANUAL FORCE AND THIS CAUSED SOME TISSUE DAMAGE. A NEW DEVICE WAS OPENED TO COMPLETE PROCEDURE AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130030 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 244163X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK