BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 7319619 · Received March 7, 2018

    Report

    Report Number
    8010047-2018-00386
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Report Date
    March 7, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    PK143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. BUT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. THE SUBJECT DEVICE WAS SENT TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, UNSPECIFIED BACTERIA (6 CFU/CHANNEL) WERE DETECTED FROM THE INSTRUMENT CHANNEL OF SUBJECT DEVICE AND UNSPECIFIED BACTERIA (5 CFU/CHANNEL) WERE DETECTED FROM THE AIR/WATER CHANNEL OF SUBJECT DEVICE. THE TEST RESULT CLEARED THE GERMAN GUIDELINE. (B)(4) DETECTED THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE WAS CUT, DURING THE EVALUATION. 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 THAT DURING A SURVEILLANCE CULTURING TEST ON (B)(6) 2018 BY THE FACILITY, THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR MICROCOCCUS SPECIES AND UNSPECIFIED BACTERIA (>300 CFU/20 ML). IT WAS ALSO INFORMED THAT THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR MICROCOCCUS SPECIES(28 CFU/20 ML) IN THE ADDITIONAL SURVEILLANCE TEST ON (B)(6). THE SUBJECT DEVICE HAD BEEN DISINFECTED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD4 (NOT AVAILABLE IN THE U.S.) WITH GLUTARALDEHYDE. THE SUBJECT DEVICE WAS MANUFACTURED AFTER AN ELEVATOR MECHANISM DESIGN CHANGE IN JANUARY 2016. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162957 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1