BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH

    MDR report key: 1010537 · Received February 18, 2008

    Report

    Report Number
    1010537
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    UPON OPENING THE ETHICON ENDOPOUCH RETRIEVER IN THE OR, IT WAS NOTED THAT THE BAND WAS BROKEN. THE PRODUCT BROKEN UPON OPENING OF PACKAGE, AND THERE WAS NO ADVERSE EVENT AS A RESULT OF THIS FAILURE. THE PRODUCT WAS RETURNED TO THE VENDOR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVAL POUCH, ENDOSCOPIC GCJ ETHICON ENDO-SURGERY, INC. * D4JNOK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR