BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III COLONOVIDEOSCOPE

    MDR report key: 25264876 · Received May 23, 2026

    Report

    Report Number
    9610595-2026-42128
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 23, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    UDI-DI
    04953170305115
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE NO IMAGE (BLACK) ISSUE WITH A SCOPE COMMUNICATION ERROR (E216) WAS TRACED TO A COMPONENT FAILURE, AND THE CAUSE OF THE WHITE RESIDUE IN THE AIR WATER CHANNEL AND CYLINDER COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER IDENTIFIED THAT THE DEVICE EXHIBITED NO IMAGE (BLACK) WITH A SCOPE COMMUNICATION ERROR (E216), ALONG WITH WHITE RESIDUE IN THE AIR WATER CHANNEL AND CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551245 EVIS EXERA III COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ190L 04953170305115

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown