BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 1812787 · Received August 17, 2010

    Report

    Report Number
    8010047-2010-00160
    Event Type
    Other
    Date Received
    August 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE 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. CROSS REFERENCE MFR. REPORT NUMBER: 8010047-2010-00XXX FOR OTHER RELATED REPORT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS REPORTEDLY 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 REPROCESSOR (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. THE USER FACILITY WAS SAID TO HAVE BEEN REPROCESSING THIS DEVICE IN THIS MANNER FOR MANY YEARS. THERE WERE NO REPORTS OF PATIENT INFECTIONS ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE FDS OLYMPUS MEDICAL SYSTEM CORPORATION GIF-2T160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1