BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 24607744 · Received March 16, 2026

    Report

    Report Number
    9610595-2026-21533
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    April 24, 2025
    Report Date
    March 16, 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

    BASED ON GWI-00019, THIS ITEM REQUIRES NO INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FORCEPS OF THE GASTROINTESTINAL VIDEOSCOPE COULD NOT BE INSERTED SMOOTHLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670606 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-2TQ260M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown