BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 25264169 · Received May 23, 2026

    Report

    Report Number
    9610595-2026-42047
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 23, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170363672
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COLONOVIDEOSCOOE HAS SCOPE COMMUNICATION ERROR B30, E216, INCOMPATIBLE SCOPE ERROR E315 AND HAS STATIC IMAGE ISSUE. THIS ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543298 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. PCF-H190DL 04953170363672

    Patients

    Seq Age Sex Outcome Treatment
    1