BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1030035 · Received April 14, 2008

    Report

    Report Number
    1717344-2008-00148
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 26, 2008
    Manufacturer
    COVIDIEN (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: APRIL 14, 2008. THE INCIDENT DEVICE IS BEING HELD AT THE SITE AND WILL NOT BE RELEASED FOR EVAL UNTIL THE MHRA GIVES THEIR CONSENT. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE DEVICE IS RETURNED FOR EVAL OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A LAPAROSCOPIC RIGHT HERNIA SURGERY THE ILEOCOLIC VESSEL WAS SEALED WITH THE LIGASURE AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INDICATION THAT ANYTHING WAS WRONG. THE PT WENT BACK TO THE WARD AND LATER BEGAN BLEEDING FROM THE ILEOCOLIC VESSEL. THE PT WAS THEN TAKEN BACK TO THE THEATRE AND THE VESSEL WAS TIED OFF. THE PT IS NOW WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN (VALLEYLAB) N7D51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention