BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24740933 · Received March 31, 2026

    Report

    Report Number
    9610595-2026-25692
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Report Date
    May 4, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: H2, H3, H6, H11. CORRECTED FIELDS: H6-MEDICAL DEVICE PROBLEM CODE REMOVE A150203, A150201, A0415, A0404. / H6-COMPONENT CODE REMOVE G04070, G02034, G04121, G04034, G040520. / H6-TYPE OF INVESTIGATION REMOVE B01. / H6-INVESTIGATION FINDINGS REMOVE C070606, C070604, C070603, C070602. / H6-INVESTIGATION CONCLUSIONS REMOVE D12. 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: NOISY IMAGE A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE IMAGE DEFECTS (SANDSTORM) AND THE NOISY IMAGE WAS TRACED TO A COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE, LIKELY DUE TO STRESS OF REPEATED USE, EXTERNAL FACTORS, OR HANDLING. 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

    DATE OF EVENT IS UNKNOWN. ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. E1: (B)(6) 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 CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED POOR IMAGE QUALITY (SNOWSTORM). THE ISSUE WAS DISCOVERED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281576 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown