BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 22806299 · Received August 14, 2025

    Report

    Report Number
    9610595-2025-17776
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 14, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170339752
    PMA / PMN Number
    K051645
    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 AND THE REPORTED FAILURE FOUND DURING INVESTIGATION WAS CONFIRMED. ACCORDING TO THE INVESTIGATION, WHITE RESIDUE WAS FOUND IN SCOPE AIR/WATER CYLINDER. HOWEVER, COMPONENT ANALYSIS OF THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT COULD NOT CONCLUSIVELY SPECIFY THE ROOT CAUSE OF THE FOREIGN MATERIAL REMAINED IN THE DEVICE. 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 WHITE RESIDUE IN THE SCOPE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT. ASSET CHECK-THE AWARE DATE WAS UPDATED TO REFLECT WHEN OLYMPUS BECAME AWARE OF THE POTENTIAL ISSUE, BASED ON THE FINDINGS OF THE QIR. MBA/24-JUN-2025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627802 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-2TH180 04953170339752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown