BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETC ETHICON

    MDR report key: 304908 · Received November 15, 2000

    Report

    Report Number
    304908
    Event Type
    Injury
    Date Received
    November 15, 2000
    Date of Event
    October 6, 2000
    Report Date
    October 20, 2000
    Manufacturer
    ETHICON
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC APPY PROCEDURE, THE ENDO-GIA STAPLING DEVICE BROKE AFTER STAPLING THE APPENDICEAL STUMP. A PIECE OF BLUE PLASTIC MATERIAL CAME FREE. THE MAIN CARTRIDGE CAME OUT OF THE STAPLING DEVICE. THE MAIN CARTRIDGE WAS EXTRACTED THROUGH THE 12-MM PORT BUT A SMALL PIECE OF BLUE PLASTIC REMAINED AND THE PROCEDURE CONVERTED TO AN OPEN SO THE FOREIGN BODY COULD BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETC ETHICON ENDO-STAPLER KOG ETHICON TSW35 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R