BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3001373 · Received March 7, 2013

    Report

    Report Number
    1717344-2013-00167
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONOPOLAR FUNCTION OF THE DEVICE WAS DIFFICULT TO ACTIVATE AFTER AN ANASTOMY WAS PERFORMED ON THE STOMACH DURING A BYPASS PROCEDURE. AT THIS TIME, THE SURGEON PULLED THE DEVICE OUT TO INSPECT IT AND LOST THE VIEW OF THE SURGICAL FIELD. AS A RESULT, A SECOND ANASTOMY WAS PERFORMED, WHICH WAS FOLLOWED BY RESECTION OF THE BOWEL. THERE WAS NO DELAY IN PROCEDURE TIME AND THE PT IS SAID TO HAVE FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98016 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 244398X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention