BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 507369 · Received January 9, 2004

    Report

    Report Number
    MW1030796
    Event Type
    Malfunction
    Date Received
    January 9, 2004
    Date of Event
    December 29, 2003
    Report Date
    January 9, 2004
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE THE GTA 55 PROXIMATE LINEAR CUTTER STAPLER DEVICE FIRED WITHOUT PROBLEMS THE FIRST TIME, BUT "MISFIRED" DURING THE SECOND ATTEMPT AT FIRING. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SURGICAL STAPLER KOG ETHICON ENDO-SURGERY GTA 55 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other