BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 3851026 · Received May 22, 2014

    Report

    Report Number
    2951238-2014-00230
    Event Type
    Other
    Date Received
    May 22, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 6, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    NWB
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION AND WAS SENT TO AN OFF-SITE INDEPENDENT LAB FOR MICROBIOLOGICAL TESTING. BASED ON THE LAB RESULTS THERE WERE MULTIPLE COCCI BACTERIA AND MOLD RECOVERED FROM THE DEVICE. THE DEVICE WAS RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE INSTRUMENT CHANNELS OF THE DEVICE WERE EXAMINED WITH A BOROSCOPE, AND A SLIGHT RESIDUE AND DEBRIS WERE NOTED INSIDE THE INSTRUMENT CHANNEL, SUCTION CYLINDER, AUXILIARY WATER CHANNEL AND OTHER INTERNAL COMPONENTS OF THE DEVICE. THERE WERE ALSO SCRAPES AND TEARS NOTED IN THE INSTRUMENT CHANNEL NEAR THE BENDING SECTION AREA. THE DEVICE WAS REFURBISHED AND RETURNED TO THE USER FACILITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, BUT INSUFFICIENT REPROCESSING CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE DID NOT PASS MULTIPLE BACTERIA TESTS. IT WAS STATED THAT THERE WERE CONSTANT HIGH READINGS OF UNSPECIFIED BACTERIA AFTER STERILIZATION. THERE WAS NO PT INFECTION OR INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY IN AN EFFORT TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT, BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306729 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROSCOPE NWB OLYMPUS MEDICAL SYSTEM CORP GIF-H180J NA

    Patients

    Seq Age Sex Outcome Treatment
    1