BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 1071243 · Received June 27, 2008

    Report

    Report Number
    1071243
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE APPENDIX, ENDOPOUCH RIPPED. THE ENTIRE BAG WAS RETRIEVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPECIMEN RETRIEVAL BAG GCJ ETHICON ENDO-SURGERY, INC. * E4KK29

    Patients

    Seq Age Sex Outcome Treatment
    1 *