BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE

    MDR report key: 1713285 · Received June 3, 2010

    Report

    Report Number
    8010047-2010-00107
    Event Type
    Other
    Date Received
    June 3, 2010
    Report Date
    May 5, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP ON THE REPORT TO OBTAIN ADDITIONAL INFO. THE USER FACILITY WAS DETERMINED NOT TO BE REPROCESSING FLEXIBLE ENDOSCOPE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES, AND PROVIDED EDUCATIONAL TRAINING MATERIALS FOR THE FACILITY STAFF. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS BECAME AWARE OF NUMEROUS SIGNIFICANT DEFICIENCIES IN THE HIGH-LEVEL DISINFECTION OF FLEXIBLE ENDOSCOPE AT THE USER FACILITY. THERE WERE DEVIATIONS IN REPROCESSING IN THE AREAS OF PRE-CLEANING, LEAK TESTING, MANUAL CLEANING, MANUAL HIGH-LEVEL DISINFECTION, DRYING AND STORAGE OF THE DEVICES. THERE WAS REPORTEDLY NO REPORTS OF PT CROSS-CONTAMINATION OR OTHER ADVERSE IMPACTS TO PTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE CYSTOSCOPE FAJ OLYMPUS MEDICAL SYSTEMS CORPORATION CYF-V2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1