BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1023289 · Received April 1, 2008

    Report

    Report Number
    1219930-2008-00263
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE ENDO GIA UNIVERSAL MISFIRED DURING THE PROCEDURE. MAYBE DUE TO A TECHNICAL ERROR IN THE LOADING MECHANISM OF THE ENDO GIA INSTRUMENT. THE SURGEON USED ANOTHER INSTRUMENT WITH THE SAME TECHNICAL ERROR. THERE WAS LEAKAGE IN THE LOWER COLON (SIGMOID). THEY USED A NEW ENDO GIA UNIVERSAL INSTRUMENT AND MADE A NEW CLOSURE WITH SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU SURGICAL STAPLING DEVICE GAG NORTH HAVEN - USS N7L321

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention N7M307| ENDO GIA UNIVERSAL 12MM SINGLE USE INST| EXPIRATION DATE: 12/31/2012| 030449