BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON COLONOSCOPE

    MDR report key: 1039404 · Received May 7, 2008

    Report

    Report Number
    2431293-2008-00006
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 16, 2008
    Manufacturer
    FUJINON, INC.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COLONOSCOPE WENT BLACK DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER COLONOSCOPE. THERE WAS NO PT INJURY. THE RETURNED SCOPE IS BEING EVALUATED. THE EXACT CAUSE OF THE INCIDENT IS NOT KNOWN.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE, THE SCOPE WENT BLACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER SCOPE. THERE WAS NO PT INJURY. THIS IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON COLONOSCOPE COLONOSCOPE FDF FUJINON, INC. EC-450HL5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other