BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 2885097 · Received December 12, 2012

    Report

    Report Number
    1717344-2012-01228
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2005
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GASTRECTOMY, THE TRANSVERSE COLON WAS PERFORMED WHILE THE DEVICE WAS IN USE. AN ADD'L SURGERY TO REPAIR THE PERFORATION WAS PERFORMED THREE DAYS AFTER THE INITIAL PROCEDURE. ADD'L INFO ON THE INCIDENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R