BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 1397213 · Received May 28, 2009

    Report

    Report Number
    8010047-2009-00095
    Event Type
    Other
    Date Received
    May 28, 2009
    Report Date
    April 29, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED UPON THE INFORMATION PROVIDED TO DATE, THE CAUSE OF THE USER'S REPORT APPEARS TO BE DUE TO USER ERROR. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST WAS DISPATCHED TO VISIT THE USER FACILITY AND PROVIDE IN-SERVICE TRAINING ON HOW TO PROPERLY REPROCESS THE DEVICES. OLYMPUS HAS CONTACTED THIS FACILITY VIA TELEPHONE AND IN WRITING, HOWEVER, NO FURTHER DETAILS HAVE BENE PROVIDED AS YET. IF SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. 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 ON RARE OCCASIONS THE FACILITY HAD CLEANED THE ENT ENDOSCOPES BY RINSING THE ENDOSCOPES IN TAP WATER AND HAND SOAP. THIS REPORTED PHENOMENON WAS IDENTIFIED IN JULY 2008. OLYMPUS WAS ALSO INFORMED THAT FOLLOWING AN INTERNAL INVESTIGATION BY THE FACILITY, A TOTAL PATIENTS THAT MAY HAVE BEEN AFFECTED WERE NOTIFIED. ONE PATIENT THAT WAS NOTIFIED WAS SAID TO HAVE HAD TESTED POSITIVE FOR HEPATITIS C. NO FURTHER DETAILED INFORMATION WAS PROVIDED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1