BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ULTRASONIC GASTROVIDEOSCOPE

    MDR report key: 3190414 · Received June 14, 2013

    Report

    Report Number
    8010047-2013-00184
    Event Type
    Other
    Date Received
    June 14, 2013
    Report Date
    May 16, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    ODG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT BUT NO FURTHER DETAILS WERE PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. THE EVALUATION FOUND CLOTTED BLOOD TRACES ON THE LIGHT-GUIDE LENS AND THE INSERTION TUBE WAS EMITTING ODOR. THE BENDING SECTION GLUE WAS CRACKED. THE INSTRUMENT CHANNEL WAS LEAKING WITH EVIDENCE OF FLUID INVASION NOTED. THE SWITCH #1 WAS INTERMITTENT AND THE ELEVATOR FLUSHING PORT WAS LOOSE. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IMPROPER REPROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE DEVICE REFERENCED IN THIS REPORT HAD BEEN SERVICED AND RETURNED TO THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT, "AFTER BRUSHING THE SCOPE 6 TIMES, THERE WERE TRACES OF BLOOD ON THE NEXT PATIENT." THERE WAS NO FURTHER DETAIL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272316 OLYMPUS ULTRASONIC GASTROVIDEOSCOPE ULTRASONIC GASTROSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORPORATION GF-UCT140-AL5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other