BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 8938439 · Received August 28, 2019

    Report

    Report Number
    8010047-2019-03101
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 18, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE SUBJECT DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, THE SAMPLE COLLECTED FROM ALL CHANNELS OF THE DEVICE TESTED POSITIVE FOR MICROCOCCACEAE (1CFU / ENDOSCOPE). THE TESTING RESULT CLEARED THE FRENCH GUIDELINE. 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. 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 MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. -THE INSTRUMENT CHANNEL: PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA (THE TOTAL CFU OF THE PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA IS 45CFU) -THE AUXILIARY CHANNEL: PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA (THE TOTAL CFU OF THE PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA IS 33CFU) -THE AIR/WATER CHANNEL: PSEUDOMONAS AERUGINOSA, STENOTROPHOMONAS MALTOPHILIA, AND BACILLUS CEREUS (THE TOTAL CFU OF THE PSEUDOMONAS AERUGINOSA, STENOTROPHOMONAS MALTOPHILIA, AND BACILLUS CEREUS IS 9CFU) -THE SUCTION CHANNEL: PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA (THE TOTAL CFU OF THE PSEUDOMONAS AERUGINOSA AND STENOTROPHOMONAS MALTOPHILIA IS >150CFU) THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE S4, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732440 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-H190I 04953170305177

    Patients

    Seq Age Sex Outcome Treatment
    1