BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS AUXILIARY WATER TUBE

    MDR report key: 2091106 · Received May 5, 2011

    Report

    Report Number
    8010047-2011-00090
    Event Type
    Other
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2008
    Report Date
    April 6, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE USER FACILITY WAS REPORTEDLY CLEANING THE MAJ-855 WITH A DETERGENT SOLUTION AS PER THE INSTRUCTIONS FOR USE, BUT THEN PLACING THE MAJ-855 AUXILIARY WATER CHANNEL IN THE AER WITHOUT CONNECTING THE TUBING TO THE FLUSHING PORT. THE AER MFR ALSO CONTRAINDICATES REPROCESSING OF THE MAJ-855 IN THE MODEL OF AER USED AT THE FACILITY. OLYMPUS WAS INFORMED THE USER FACILITY HAS SINCE IMPLEMENTED APPROPRIATE REPROCESSING METHODS. AS PART OF THE INVESTIGATION INTO THIS REPORT AN OLYMPUS' ENDOSCOPY SUPPORT SPECIALIST (ESS) HAVE BEEN DISPATCHED TO THE USER FACILITY TO F/U AND PROVIDE ANY NECESSARY IN-SERVICE TRAINING ON APPROPRIATE REPROCESSING METHODS. 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 AUXILIARY WATER TUBE IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THE USER FACILITY PERSONNEL WERE REPORTEDLY PLACING THE AUXILIARY WATER TUBE INSIDE THE BASIN OF THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WITHOUT CONNECTING THE MAJ-855 TO ANY OF THE FLUSHING CONNECTORS OF THE AER. IN THIS CONFIGURATION, IT IS UNLIKELY THAT THE INTERIOR OF THE MAJ-855 TUBING WAS BEING ADEQUATELY FLUSHED WITH DISINFECTANT. THIS PRACTICE WAS SAID TO HAVE BEEN ONGOING SINCE SOME TIME IN 2008. THERE WERE NO REPORTS OF ANY ADVERSE IMPACT TO PT OR USERS ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AUXILIARY WATER TUBE AUXILIARY WATER TUBE FDS OLYMPUS MEDICAL SYSTEM CORPORATION MAJ-855 NA

    Patients

    Seq Age Sex Outcome Treatment
    1