BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 6600205 · Received May 31, 2017

    Report

    Report Number
    8010047-2017-10098
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    PMA / PMN Number
    K112680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 SCHWEIZ AG (OAG). FOLLOWING ADDITIONAL HIGH LEVEL DISINFECTION AT OAG, THE SUBJECT DEVICE WAS SEND TO A THIRD PARTY LABORATORY FOR ADDITIONAL MICROBIOLOGICAL TESTING. IN THE ADDITIONAL TEST, THE TESTING INDICATED NO MICROORGANISM GROWTH FOR THE SUBJECT DEVICE. OAG WILL FOLLOW UP WITH THE FACILITY TO ASSESS THE REPROCESSING PROCEDURE. THE EXACT CAUSE COULD NOT BE DETERMINED AT PRESENT, IF SIGNIFICANT 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 BY THE FACILITY, THE SUBJECT DEVICE TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA (4CFU/ML). THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381237 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CF-HQ190I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1