BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24041332 · Received January 12, 2026

    Report

    Report Number
    9610595-2026-03551
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    November 5, 2025
    Report Date
    January 12, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K222584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A DEFINITE ROOT CAUSE COULD NOT BE IDENTIFIED TRACING TO THE DEVICE MALFUNCTIONS AIR/WATER-TUBE HAS FOREIGN OBJECTS, AIR/WATER-CYLINDER (TUBE) HAS FOREIGN OBJECTS AND J-TUBE (AUXILIARY JET CHANNEL) HAS FOREIGN OBJECTS. OLYMPUS CONFIRMED FOREIGN MATERIAL CAME OUT OF THE DEVICE, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE MALFUNCTION "DENT ON J-TUBE (AUXILIARY JET CHANNEL) IN CONTROL UNIT" WAS TRACED TO COMPONENT FAILURE. 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 OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE J-TUBE (AUXILIARY JET CHANNEL), AIR/WATER CHANNEL, AIR/WATER CYLINDER AND A DENT ON J-TUBE (AUXILIARY JET CHANNEL) IN CONTROL UNIT . THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99362 GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown