BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 1874243 · Received October 11, 2010

    Report

    Report Number
    8010047-2010-00205
    Event Type
    Other
    Date Received
    October 11, 2010
    Report Date
    September 13, 2010
    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 SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) HAS VISITED THE USER FACILITY AND PROVIDED IN-SERVICE TRAINING ON APPROPRIATE REPROCESSING OF ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT REPROCESSING THE SUBJECT DEVICE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY WAS REPORTEDLY CONNECTING NON-OLYMPUS ACCESSORIES TO THE INSTRUMENT CHANNEL PORTS DURING REPROCESSING IN THE FACILITY'S AUTOMATIC ENDOSCOPE RE-PROCESSOR (AER). USE OF THE NON-OLYMPUS ACCESSORIES WOULD LIKELY RESULT IN ONE OR BOTH OF THE DUAL INSTRUMENT CHANNELS NOT BEING ADEQUATELY FLUSHED DURING REPROCESSING. USER FACILITY PERSONNEL STATED THAT THIS PRACTICE HAD BEEN IN USE FOR MANY YEARS. THERE WERE NO REPORTS OF PATIENT INFECTIONS OR OTHER ADVERSE IMPACTS ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION GIF-2T1606 NA

    Patients

    Seq Age Sex Outcome Treatment
    1