BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA ¿ COLONOVIDEOSCOPE

    MDR report key: 6992592 · Received November 1, 2017

    Report

    Report Number
    8010047-2017-01622
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 6, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    PMA / PMN Number
    PK001241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) SENT THE DEVICE TO A THIRD PARTY LABORATORY FOR MICROBIOLOGICAL TESTING. AS A RESULT OF THE TESTING, NO MICROBE WAS DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. THE TESTING RESULT CLEARED THE GERMAN GUIDELINE. CRACKS ON THE LIGHT GUIDE LENS. DAMAGE OF THE GLUE AROUND THE LENSES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC. 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 AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE INSTRUMENT CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR MYCOBACTERIUM LENTIFLAVUM. THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS REPROCESSED ACCORDING TO THE INSTRUCTION FOR USE. THE SUBJECT DEVICE HAD BEEN REPROCESSED USING AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSR MODEL ETD3 (NOT AVAILABLE IN THE U.S.). THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771876 EVIS EXERA ¿ COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. CF-Q165L

    Patients

    Seq Age Sex Outcome Treatment
    1