BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 6921417 · Received October 6, 2017

    Report

    Report Number
    8010047-2017-10109
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS
    Product Code
    FDF
    UDI-DI
    04953170305139
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REGARDING THIS EVENT, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) SUBMITTED THE INITIAL MDR (#8010047-2017-01428), BUT OMSC COULD NOT CONFIRM THE FDA RECEIVED IT. THEN, OMSC SUBMITTED THIS MFR REPORT ON ANOTHER SYSTEM. AFTER THAT, OMSC CONFIRMED THE ACKNOWLEDGEMENT THAT THE FDA RECEIVED THE MDR(#8010047-2017-01428) SUBMITTED FIRST. THEREFORE, OMSC RETRACTED THIS MFR REPORT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT (B)(4), THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, PSEUDOMONAS-AERUGINOSA-GROUP (NOT PSEUDOMONAS-AERUGINOSA) WERE DETECTED FROM THE AIR/WATER CHANNEL OF SUBJECT DEVICE. OMSC REVIEWED THE MANUFACTURING HISTORY 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 IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED BACTERIA. THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE PREPROCESSOR MODEL MINI ETD 2 (NOT AVAILABLE IN THE U.S.) WITH PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705503 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CF-HQ190I 04953170305139

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening