BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 2823536 · Received August 21, 2008

    Report

    Report Number
    8010047-2007-00211
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 23, 2007
    Report Date
    July 31, 2007
    Manufacturer
    OLYMPUS MEDICAL CO. LTD.
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR INVESTIGATION. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST (CSS) VISITED THE USER FACILITY AND DETERMINED THAT THE ENDOSCOPE ACCESSORIES WERE NOT BEING REPROCESSED APPROPRIATELY. THE ESS PROVIDED TRAINING AND EDUCATIONAL MATERIALS TO THE USER FACILITY'S STAFF REGARDING APPROPRIATE REPROCESSING METHODS FOR THEIR ENDOSCOPE ACCESSORIES. THE CAUSE OF THE PTS' OUTCOMES APPEARS TO BE DUE TO USER ERROR AND FAILURE TO FOLLOW OLYMPUS' INSTRUCTIONS IN REPROCESSING THE AUXILIARY WATER TUBE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT HIGH-LEVEL CHEMICAL DISINFECTANT RESIDUE HAD BEEN FOUND INSIDE THE AUXILIARY WATER TUBE THAT WAS UTILIZED WITH DIFFERENT MODELS OF THE USER FACILITY'S ENDOSCOPES, AND THREE TO FOUR PTS THAT HAD RECEIVED ENDOSCOPY PROCEDURES AT THEIR FACILITY HAVE BEEN HOSPITALIZED FOR WHAT APPEARS TO BE CHEMICAL COLITIS. THE USER FACILITY REPORTED THAT THE PTS WERE PROVIDED WITH MEDICATION BUT NO SURGERIES WERE NECESSARY. THE USER FACILITY ALSO REPORTED THAT THE PTS WERE ALL RELEASED FROM THE HOSPITAL AND ALL WERE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AUXILLIARY WATER TUBE FDS OLYMPUS MEDICAL CO. LTD. MAJ-855 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention