BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 10166207 · Received June 18, 2020

    Report

    Report Number
    8010047-2020-03447
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 26, 2020
    Report Date
    October 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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. THE EVALUATION OF THE DEVICE CONFIRMED THE FOLLOWINGS; THE MANUFACTURING HISTORY (DHR) CONFIRMED NO IRREGULARITY. BROWN FOREIGN MATERIALS IN THE CHANNEL NEAR THE DISTAL END AND SUCTION CYLINDER WERE NOTED. AS A RESULT OF THE ANALYSIS, OMSC SPECULATED THAT THE BROWN FOREIGN MATERIALS WERE DERIVED FROM METAL RUST. WHITE FOREIGN MATERIALS ON THE DISTAL END WERE NOTED. AS A RESULT OF THE ANALYSIS, OMSC SPECULATED THAT THE WHITE FOREIGN MATERIALS WERE SODIUM CHLORIDE. SCRATCHES ON THE CHANNEL OF THE BENDING SECTION WERE NOTED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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 TWO MICROBIOLOGICAL TESTS BY THE USER FACILITY ON (B)(6) 2020, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. PSEUDOMONAS AERUGINOSA, COAGULASE NEGATIVE STAPHYLOCOCCUS THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, ESR-100, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635189 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1