BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2598658 · Received June 2, 2012

    Report

    Report Number
    8010047-2012-00174
    Event Type
    Other
    Date Received
    June 2, 2012
    Report Date
    May 4, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THIS FACILITY AND PROVIDED IN-SERVICE TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES. IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTIONS AND REPROCESSING MANUALS PROVIDE DETAILED INFO ON HOW TO REPROCESS ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE USER FACILITY WAS NOT BRUSHING THE SCOPE CHANNELS CONSISTENTLY. ADDITIONALLY, THE USER FACILITY REPORTEDLY WAS NOT PERFORMING PRECLEANING, AND NOT ALL STEPS IN THE LEAK TESTING PROCESS WAS BEING PERFORMED. THE USER FACILITY WAS ALSO SAID TO HAVE REUSED AND REPROCESSED THE OLYMPUS BW-201T SINGLE USE CLEANING BRUSH. THERE HAD BEEN NO REPORT OF INFECTION AND CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1