BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24941850 · Received April 21, 2026

    Report

    Report Number
    9610595-2026-32603
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 21, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H3, H4, H6, H11. CORRECTED FIELDS: G4, H6 (A090203 REMOVED). THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: FOREIGN OBJECT INSIDE THE SECONDARY WATER SUPPLY TUBE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE MOST PROBABLE ROOT CAUSE OF THE REPORTED MALFUNCTION WAS DAMAGED CIRCUIT BOARD OF SCOPE CONNECTOR (S-CONNECTOR) AND THE MOST PROBABLE ROOT CAUSE OF THE FOREIGN OBJECT INSIDE THE SECONDARY WATER SUPPLY TUBE COULD NOT BE ESTABLISHED. 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

    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

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE DISPLAYED AN E216 SCOPE COMMUNICATION ERROR MESSAGE AND THE IMAGE WAS NOISY. THE ISSUE OCCURRED DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998991 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290Z

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown