BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 11911057 · Received May 31, 2021

    Report

    Report Number
    8010047-2021-06921
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OMSC BUT IS CURRENTLY QUARANTINED IN OLYMPUS (B)(6) (OIE). OIE REQUIRES THE CUSTOMER FOR MORE INFORMATION, BUT THE CUSTOMER DOSE NOT HAVE ACCESS TO MICROBIOLOGICAL TESTING RESULT DUE TO CYBERATTACKS. 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.

    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 SAMPLE COLLECTED FROM THE DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. AND THE TOTAL VIABLE COUNT DETECTED IN THE SAMPLE WAS HIGH. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803477 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1