BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTREE II VALVE/REDUCER

    MDR report key: 496648 · Received November 17, 2003

    Report

    Report Number
    1317214-2003-00065
    Event Type
    Malfunction
    Date Received
    November 17, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 17, 2003
    Manufacturer
    CORE DYNAMICS
    Product Code
    FBM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "DURING AN ENDO-GI PROCEDURE, THE SEAL FELL OUT OF THE REDUCER AND FELL INTO THE SURGICAL FIELD. IT WAS RETRIEVED AND THERE WAS NO PATIENT INJURY OR ALTERNATION OF THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTREE II VALVE/REDUCER ENDO VALVE/REDUCER FBM CORE DYNAMICS NA CC306604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN