BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX45

    MDR report key: 1051501 · Received May 12, 2008

    Report

    Report Number
    1051501
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO THE OR FOR A LAPAROSCOPIC-ASSISTED LEFT COLON RESECTION. DURING THE PROCEDURE, THE SURGEON WENT TO USE THE INVOLVED DEVICE AND IT MISFIRED. THE STAPLE CARTRIDGE "FELL OUT" OF THE GUN AND LANDED IN THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE THE CARTRIDGE AND ACQUIRED A NEW STAPLER/CUTTING DEVICE, WHICH HE USED TO FINISH THE PROCEDURE. NO INJURY TO THE PATIENT WAS NOTED. ALL INVOLVED COMPONENTS WERE RETRIEVED AND SEQUESTERED. THE PATIENT WAS SENT TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX45 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ATW45 E4K82K

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR