BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 2926246 · Received January 16, 2013

    Report

    Report Number
    1717344-2013-00021
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 19, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE JAWS OF THE DEVICE WOULD NOT OPEN AFTER CLOSING ON TISSUE. THERE WAS A TEAR IN THE VESSEL WHEN THE DEVICE WAS REMOVED. THE PT LOST 700 CC IN BLOOD AND THE PROCEDURE WAS CONVERTED TO OPEN. A SECOND DEVICE WAS USED TO SEAL THE VESSEL AND THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24864 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention