BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 25019720 · Received April 28, 2026

    Report

    Report Number
    9610595-2026-34558
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTION WAS IDENTIFIED DURING THE DEVICE EVALUATION: 1.AW-CYLINDER (TUBE) HAS FOREIGN OBJECTS. (WHITE FOREIGN MATERIAL). 2.AW-TUBE HAS FOREIGN OBJECTS. (WHITE FOREIGN MATERIAL). 3.NOZZLE HAS FOREIGN OBJECTS. 4.UNIVERSAL CORD HAS FOREIGN OBJECTS. BASED ON THE RESULTS OF THE INVESTIGATION, THE FOREIGN MATERIAL WAS LIKELY CAUSED BY KNOWN INHERENT RISK; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A FOREIGN OBJECT PRESENT IN THE SUCTION CHANNEL. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080746 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H180

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown