BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EC-250HL5

    MDR report key: 722991 · Received May 8, 2006

    Report

    Report Number
    722991
    Event Type
    Malfunction
    Date Received
    May 8, 2006
    Date of Event
    April 11, 2006
    Report Date
    May 8, 2006
    Manufacturer
    FUJINON, INC.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A COLONOSCOPY WAS BEING PERFORMED BY THE PHYSICIAN. DURING THE PROCEDURE, YELLOW FLUID REFLUXED THROUGH THE FLUSHING CHANNEL OF THE COLONOSCOPE INTO THE TUBING THAT ATTACHES TO THE WATER BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EC-250HL5 COLONOSCOPE FDF FUJINON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR