BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24468166 · Received February 27, 2026

    Report

    Report Number
    9610595-2026-17809
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    December 2, 2025
    Report Date
    February 27, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. THE DEVICE EVALUATION FOUND THE BIOPSY CHANNEL, THE SMALL LIGHT GUIDE COVER LENS, THE LARGE LIGHT GUIDE COVER LENS, THE TWO LIGHT GUIDE ROD LENSES, THE SUCTION CYLINDER AND THE AIR/WATER CHANNEL OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIALS. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED THE DEVICE HAD FOREIGN MATERIAL, BUT THE TYPE OF MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE BIOPSY CHANNEL, THE SMALL LIGHT GUIDE COVER LENS, THE LARGE LIGHT GUIDE COVER LENS, THE TWO LIGHT GUIDE ROD LENSES, THESUCTION CYLINDER AND THE AIR/WATER CHANNEL OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIALS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529867 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown