BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA II

    MDR report key: 2240590 · Received August 24, 2011

    Report

    Report Number
    8010047-2011-00193
    Event Type
    Other
    Date Received
    August 24, 2011
    Report Date
    July 26, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO OLYMPUS FOR EVAL. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) HAS VISITED THE USER FACILITY AND PROVIDED INSERVICE TRAINING AND EDUCATIONAL MATERIALS REGARDING APPROPRIATE REPROCESSING OF ENDOSCOPES. THIS PHENOMENON APPEARS TO BE RELATED TO USER ERROR, AND FAILING TO FOLLOW THE DEVICE INSTRUCTIONS FOR USE. 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 REPROCESSING ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE FACILITY REPORTED THEY WERE NOT UTILIZING THE AIR/WATER CLEANING ADAPTER, AND NOT CHANGING WATER FROM WASHING AND RINSING SINKS BETWEEN REPROCESSING OF DIFFERENT ENDOSCOPES. FURTHER THE USER FACILITY PERSONNEL WERE NOT REPROCESSING THE MAJ-855 AUXILIARY WATER TUBE AT ALL. THERE WERE NO REPORTS OF PT INFECTIONS OR CROSS CONTAMINATION ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) AUXILIARY WATER TUBE