BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 2804004 · Received October 15, 2012

    Report

    Report Number
    MW5027308
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAPLER, WHEN LOADED AND IN THE ABDOMEN WOULD NOT LOCK AROUND THE APPENDIX, BUT IT CUT THE APPENDIX, A DECISION WAS MADE TO CONVERT TO AN OPEN APPENDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC ARTICULATING ENDOSCOPIC LINEAR CUTTER KOG ETHICON ENDO-SURGERY ATS45 J4CA8U

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR