BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPES

    MDR report key: 2162267 · Received July 6, 2011

    Report

    Report Number
    8010047-2011-00146
    Event Type
    Other
    Date Received
    July 6, 2011
    Report Date
    June 14, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS WAS INFORMED THAT THE USER FACILITY HAD NOT USED OR REPROCESSED THE AUXILIARY WATER CHANNEL OF SOME ENDOSCOPES FOR AN UNSPECIFIED PERIOD OF TIME. THE USERS WERE NOT LEAK TESTING EVERY SCOPE, NOR USING INJECTION TUBING TO FLUSH SCOPE CHANNEL, AND WERE REPORTEDLY RINSING ENDOSCOPES UNDER RUNNING WATER. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS PROVIDED FOLLOW-UP IN-SERVICE TRAINING AT THE USER FACILITY TO REVIEW THE APPROPRIATE REPROCESSING OF ENDOSCOPES AND TO PROVIDE PROPER REPROCESSING TRAINING TO THE USERS. BASED UPON THE INFORMATION PROVIDED, THIS ISSUE WAS RELATED TO USER ERROR. 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 HAD NOT REPROCESSED THE AUXILIARY WATER CHANNEL OF SOME ENDOSCOPES FOR AN UNSPECIFIED PERIOD OF TIME, AND WERE NOT REPROCESSING ENDOSCOPES IN ACCORDANCE WITH THE DIRECTIONS FOR USE. THERE WERE NO REPORTS OF INFECTIONS OR OTHER PATIENT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1