BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS GASTROSCOPE

    MDR report key: 2307929 · Received October 17, 2011

    Report

    Report Number
    8010047-2011-00241
    Event Type
    Other
    Date Received
    October 17, 2011
    Report Date
    September 20, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO AN OLYMPUS SVC CTR AND EVALUATED. THE EVAL DID NOT IDENTIFY ANY NON-CONFORMITIES WITH THE DEVICE. THE UNIT WAS INSPECTED AND RETURNED TO THE CUSTOMER. THE USER FACILITY REPORTED THEY WERE NOT FLUSHING THE AUXILIARY WATER TUBE AS PART OF THE REPROCESSING STEPS. BASED ON THE INFO PROVIDED BY THE USER FACILITY, THE SUBJECT DEVICE WAS NOT REPROCESSED ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) HAS VISITED THE USER FACILITY AND PROVIDED TRAINING ON APPROPRIATE REPROCESSING OF 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 A BROWN OR BLACK SUBSTANCE WAS EXPELLED FROM THE GASTROSCOPE WHEN THE USER FACILITY STAFF REPROCESSED THE AUXILIARY WATER CHANNEL OF THE SUBJECT DEVICE. THE STAFF FURTHER REPORTED THAT THE AUXILIARY WATER CHANNEL HAD NOT BEEN FLUSHED DURING REPROCESSING FOR AN EXTENDED PERIOD OF TIME, DURING WHICH THE ENDOSCOPE HAD BEEN IN USE. THERE WERE NO REPORTS OF PT INFECTIONS ASSOCIATED WITH THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE GASTROSCOPE GCK OLYMPUS MEDICAL SYSTEM CORPORATION GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1