BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 25266238 · Received May 23, 2026

    Report

    Report Number
    9610595-2026-42195
    Event Type
    Malfunction
    Date Received
    May 23, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 23, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K222584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    THE CUSTOMER REPORTED A SCOPE COMMUNICATION ERROR (E226) DURING INSPECTION FOR USE INVOLVING AN OLYMPUS COLONOVIDEOSCOPE.. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87081 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-HQ1100DL

    Patients

    Seq Age Sex Outcome Treatment
    1