BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO SURGERY INC.

    MDR report key: 571101 · Received February 8, 2005

    Report

    Report Number
    571101
    Event Type
    Injury
    Date Received
    February 8, 2005
    Date of Event
    January 26, 2005
    Report Date
    January 26, 2005
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TSW35 STAPLER INTRODUCED INTO ABDOMINAL CAVITY BY SURGEON. TISSUE GRASPED, STAPLER FIRED. STAPLER CARTRIDGE SUBSEQUENTLY FELL OUT OF HANDLE. CARTRIDGE RETRIEVED WITH ENDOPOUCH. PARTIAL STAPLE FIRING AHD OCCURRED REQUIRING CONVERSION TO OPEN APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO SURGERY INC. ENDOSCOPIC LINEAR CUTTER KOG ETHICON ENDO-SURGERY, INC. * Y43X1Z

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| O| R