BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON DUODENOSCOPE

    MDR report key: 1212697 · Received October 22, 2008

    Report

    Report Number
    2431293-2008-00008
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    September 30, 2008
    Manufacturer
    FUJINON, INC.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PROBLEM HAS ONLY OCCURRED WHEN BOSTON SCIENTIFIC MICROVASIVE ERCP ACCESSORIES ARE BEING USED WITH THE DEVICE. THE EXACT CAUSE IS UNDER INVESTIGATION. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    IN 2008, CO RECEIVED A COMPLAINT FORM REGARDING AN POTENTIAL INCIDENT. THE REPORT INDICATED THAT ACCESSORIES WERE GETTING LODGED IN THE DUODENOSCOPE. ACCORDING TO THE CUSTOMER, THE THERAPEUTIC OBJECTIVE OF THE PROCEDURE COULD NOT BE ATTAINED BECAUSE OF THIS DIFFICULTY WITH THE ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON DUODENOSCOPE DUODENOSCOPE FDT FUJINON, INC. ED-530XT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other