BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 3593243 · Received January 10, 2014

    Report

    Report Number
    2951238-2014-00004
    Event Type
    Other
    Date Received
    January 10, 2014
    Date of Event
    December 16, 2013
    Report Date
    October 19, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENT TO AN OFF-SITE LABORATORY FOR MICROBIOLOGICAL TESTING. THE RESULTS OF THE TESTING ARE NOT YET AVAILABLE. A PHYSICAL EVALUATION OF THE DEVICE WILL FOLLOW ONCE THE DEVICE IS RECEIVED FROM THE LABORATORY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE LATER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT A DUODENOVIDEOSCOPE WAS CULTURED AS PART OF THE USER FACILITY'S SURVEILLANCE TESTING. THE TEST RESULTS INDICATED THAT THE DUODENOVIDEOSCOPE TESTED POSITIVE FOR KLEBSIELLA PNEUMONIAE AND E-COLI (BOTH DRUG RESISTANCE VERSIONS). OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20680 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION TJF-Q180V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other