BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8746917 · Received June 30, 2019

    Report

    Report Number
    8010047-2019-02378
    Event Type
    Malfunction
    Date Received
    June 30, 2019
    Date of Event
    May 20, 2019
    Report Date
    October 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305177
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE SERIE4, AND SOMETIMES MANUALLY DISINFECTED WITH PERACETIC ACID. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS FRANCE.(OFR). OFR SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR COMAMONAS TESTOSTERONI (1CFU/ENDOSCOPE). THE TESTING RESULT WAS TARGET LEVEL IN THE FRENCH GUIDELINE. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. THE AIR/WATER CHANNEL: MICROCOQUE AND CORYNEBACTERIUM. (THE TOTAL CFU OF THE MICROCOQUE AND CORYNEBACTERIUM IS 7CFU/100ML). THE AUXILIARY CHANNEL: ENTEROBACTERIA GROUP KES (INNUMERABLE / 100ML). THE INSTRUMENT CHANNEL: MICROCOQUE (22CFU / 100ML). THE SUCTION CHANNEL: MICROCOQUE (4CFU / ML). THE DEVICE HAD BEEN MANUALLY REPROCESSED USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540379 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1