BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLONOVIDEOSCOPE

    MDR report key: 24965158 · Received April 23, 2026

    Report

    Report Number
    9610595-2026-33213
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 25, 2026
    Report Date
    May 11, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDF
    PMA / PMN Number
    K250432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, A PROBABLE ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE ADDITION INFORMATION RECEIVED FROM THE CUSTOMER. UPDATED FIELDS: B5, H2, H11 A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED MALFUNCTION INCOMPATIBLE SCOPE ERROR (E315) WAS NOT CONFIRMED, AND THE MOST PROBABLE CAUSE 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

    IT WAS REPORTED THAT THE COLONOVIDEOSCOPE DISPLAYED ERROR CODE E316. THE ISSUE WAS IDENTIFIED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: AS PER THE DUE DILIGENCE (DD-222349), THE CORRECT ERROR WAS AN INCOMPATIBLE SCOPE ERROR (E315).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249032 COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF AIZU OLYMPUS CO., LTD. CF-EZ1500DL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown