BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 24991406 · Received April 25, 2026

    Report

    Report Number
    3002808148-2026-04605
    Event Type
    Malfunction
    Date Received
    April 25, 2026
    Date of Event
    December 3, 2025
    Report Date
    April 25, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    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. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE MALFUNCTION FOUND DURING DEVICE EVALUATION IS 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. THE B4 -DATE OF THIS REPORT IS 2/19/2026, WHICH IS NOT LATE. A COMPLAINT HANDLING SYSTEM VENDOR TICKET WAS OPENED TO INVESTIGATE THE ISSUE UNDER TICKET # 359525 WITH THE FDA. PER FDA REQUEST FROM TICKET CSH-41299 EVEN THOUGH ACK 1 AND ACK 2 WERE SUCCESSFUL ON 2/19/2026 IT WAS REQUESTED THIS EMDR TO BE RE-SUBMITTED AS IT IS NOT ABLE TO BE LOCATED IN THE GATEWAY.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASOUND GASTROVIDEOSCOPE HAD CUT ON THE PINK RUBBER PROBE, AND PEELING GLUE AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568532 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown