BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 2197700 · Received July 28, 2011

    Report

    Report Number
    8010047-2011-00176
    Event Type
    Other
    Date Received
    July 28, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 29, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS VISITED THIS FACILITY AND PROVIDED IN-SERVICE TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES. NO PRODUCTS WERE RETURNED TO OLYMPUS FOR EVAL. IF ADDITIONAL AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTION AND/OR REPROCESSING MANUALS PROVIDE DETAILED INFO ON HOW TO REPROCESS THE SUBJECT ENDOSCOPE. THE CAUSE OF THIS REPORT APPEARS TO BE DUE TO USER ERROR. PLEASE ALSO REFERENCE MFR REPORT # 8010047-2011-00175. 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 DURING UNSPECIFIED BARIATRIC PROCEDURE, THE USERS DETECTED DRIED BLOOD OR OTHER BIOMATERIAL ON THE DISTAL END OF THE SCOPE. THE SUBJECT DEVICE WAS REPORTEDLY NOT USED ON A PT. THE INTENDED PROCEDURE WAS COMPLETED WITH A DIFFERENT ENDOSCOPE. THE USER FACILITY REPORTED THT TWO OLYMPUS ENDOSCOPES WERE BEING USED DURING THE (B)(6) TIMEFRAME IN WHICH THE AUXILIARY WATER CHANNELS WERE NOT BEING REPROCESSED AS THE USER FACILITY ALLEGED THAT THEY WERE UNAWARE OF THE PRESENCE OF THIS CHANNEL IN THESE ENDOSCOPES. 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