BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3221412 · Received June 28, 2013

    Report

    Report Number
    1717344-2013-00479
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED, OR 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 DURING A BOWEL RESECTION, THE DEVICE COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. THE BLADE WAS IN THE FULLY DEPLOYED POSITION ON THICK SMALL BOWEL MESENTERY. ANOTHER DEVICE WAS USED TO FREE THE JAWS OF THE DEVICE FROM THE MESENTERY. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295294 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2MF026X

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR