BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOGIA STAPLER

    MDR report key: 1161763 · Received September 10, 2008

    Report

    Report Number
    1161763
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDOGIA WAS FIRED TO TRANSECT THE APPENDIX. ON REMOVAL OF THE INSTRUMENT, IT WAS FOUND TO HAVE CUT THROUGH THE CECUM WITHOUT DEPLOYING THE STAPLES, THEREBY LEAVING AN OPENING IN THE CECUM. PROCEDURE HAD TO BE CONVERTED FROM LAPAROSCOPIC TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOGIA STAPLER STAPLER, SURGICAL GAG ETHICON ENDO-SURGERY, INC. * E4LN1W

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR