BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPES

    MDR report key: 2066578 · Received April 12, 2011

    Report

    Report Number
    8010047-2011-00079
    Event Type
    Other
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP ON THIS MATTER AND WAS INFORMED THAT THE USERS HAD NOTED A FILM ON THE SURFACES OF THE ENDOSCOPES. 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 ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. OLYMPUS INSTRUCTION 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 REPROCESSING THE ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY PERSONNEL WERE REPORTEDLY NOT FLUSHING THE AUXILIARY WATER CHANNEL DURING PRE-CLEANING, AND THE AUXILIARY WATER CHANNEL CONNECTOR WAS NOT BEING ATTACHED IN THE AUTOMATED ENDOSCOPE REPROCESSOR (AER) DURING REPROCESSING. THERE HAD BEEN NO REPORT OF INFECTION AND CROSS CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPES ENDOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORPORATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS OER-PRO ENDOSCOPE REPROCESSOR| SERIAL NUMBER (B)(4)