BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPE

    MDR report key: 2507450 · Received March 7, 2012

    Report

    Report Number
    8010047-2012-00059
    Event Type
    Other
    Date Received
    March 7, 2012
    Report Date
    February 9, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED FOR EVALUATION. BASED UPON THE INFORMATION PROVIDED, THE USER FACILITY WAS NOT REPROCESSING THEIR ENDOSCOPES IN ACCORDANCE TO THE INSTRUCTIONS FOR USE. THE USER FACILITY HAD BEEN REPROCESSING THE SUBJECT DEVICE IN AN AUTOMATIC ENDOSCOPY PREPROCESSOR, BUT HAD NOT BEEN REPROCESSING THE AUXILIARY WATER CHANNEL. AN OLYMPUS ENDOSCOPE SERVICE SPECIALIST (ESS) HAS VISITED THE USER FACILITY, AND PROVIDED IN-SERVICE TRAINING REGARDING THE APPROPRIATE REPROCESSING OF ENDOSCOPES. THE ESS HAS ALSO PROVIDED THE USER FACILITY REPROCESSING DVD'S AND EDUCATIONAL MATERIALS FOR ADDITIONAL REFERENCE. THIS REPORT APPEARS TO BE DUE 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 BEEN REPROCESSING THE AUXILIARY WATER CHANNEL OF ALL THEIR ENDOSCOPES FOR AN UNSPECIFIED PERIOD. THERE WERE NO REPORTS OF ANY PT OR USER INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPE ENDOSCOPES GCQ OLYMPUS MEDICAL SYSTEM CORP ENDOCOPES NA

    Patients

    Seq Age Sex Outcome Treatment
    1