BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 2061051 · Received April 1, 2011

    Report

    Report Number
    8010047-2011-00067
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 4, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE SUBJECT DEVICE UNDERWENT TWO REPROCESSING CYCLES WITH CIDEX IN A CUSTOM ULTRASONIC REPROCESSOR IN WHICH THE REPROCESSOR WAS INSPECTED REGULARLY. THE SUBJECT DEVICE WAS REPORTEDLY CULTURED FOLLOWING THE REPORTED INCIDENCE AND THE RESULT WAS NEGATIVE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE INSTRUMENT CHANNEL, SUCTION CHANNEL, CYLINDER UNIT, AND THE AREA AROUND THE AIR/WATER NOZZLE WERE INSPECTED WITH A BAROSCOPE AND A RIGID TELESCOPE WITH SMALL AMOUNT OF WHITE RESIDUE AND DEBRIS OBSERVED. THE SCOPE PASSED THE LEAKAGE TEST AND THE FOG TEST. THE IMAGE AND THE SWITCHES WERE FOUND WITH NO ISSUES. THE REPORTED PHENOMENON WAS ATTRIBUTED TO INSUFFICIENT CLEANING AND IMPROPER REPROCESSING. THIS IS ONE OF TWO REPORTS. PLEASE ALSO CROSS REFERENCE MFR REPORT NUMBER: 8010047-2011-00068. 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 TWO PATIENTS MAY HAVE EXPOSED TO THE PNEUMONIA ORGANISM FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES CONDUCTED WITH THE SUBJECT DEVICE ON DIFFERENT DAYS. THE TWO PATIENTS WERE REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE DUODENSCOPE KOG OLYMPUS MEDICAL SYSTEM CORPORATION TJF-160VF NA

    Patients

    Seq Age Sex Outcome Treatment
    1