BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 859359 · Received May 29, 2007

    Report

    Report Number
    MW5002150
    Event Type
    Injury
    Date Received
    May 29, 2007
    Date of Event
    May 25, 2007
    Report Date
    May 29, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A LINEAR CUTTING STAPLER WAS INSERTED AND FIRED ACROSS THE BASE OF THE PATIENT'S APPENDIX. IT DID DIVIDE THE APPENDIX, BUT IT APPEARED THAT IT DID NOT STAPLE THE APPENDIX, AND THE CARTRIDGE ACTUALLY FELL OUT OF THE STAPLER. THE CARTRIDGE WAS REMOVED USING LAPAROSCOPIC GRASPERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ENDOSCOPIC LINEAR CUTTER GCJ ETHICON ENDO-SURGERY, INC. REF TSB 35 [1 D4H17F

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability