BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3596360 · Received January 14, 2014

    Report

    Report Number
    2951238-2014-00010
    Event Type
    Other
    Date Received
    January 14, 2014
    Report Date
    December 16, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL UNDER EVAL BY OLYMPUS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE LATER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A DUODENOVIDEOSCOPE WAS CULTURED POSITIVE FOR AN UNK ORGANISM. IN ADDITION, THE DUODENOVIDEOSCOPE HAD A BROKEN ELEVATOR. OLYMPUS FOLLOWED UP WITH THE RPTR TO OBTAIN ADD'L INFO REGARDING THE EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37699 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION TJF-160VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other