BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III DUODENOVIDEOSCOPE

    MDR report key: 22841639 · Received August 19, 2025

    Report

    Report Number
    2429304-2025-00231
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 17, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECT F10 HEALTH EFFECT: CLINICAL CODE FROM E2403: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS TO E2008: FOREIGN BODY IN PATIENT.

    Description of Event or Problem · 0

    CORRECTION IS BEING MADE TO THE PREVIOUSLY SUBMITTED IMPORTER REPORT WITH REFERENCE NUMBER: 2429304-2025-00231-01. CORRECTED FIELD: F6: DATE USER FACILITY/IMPORTER WAS AWARE, WHICH WAS NOT LATE. THE CORRECT DATE WAS 09/15/2025.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    THE DAY AFTER A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, AFTER THE PATIENT WOKE UP THEY DISCOVERED THAT THE DISTAL TIP HAD FALLEN OFF THE PATIENT. THERE WAS NO FURTHER INFORMATION ON ANY DIAGNOSTIC IMAGING DONE TO CONFIRM DEVICE FALL OUT, AND NO INFORMATION ON ANY MEDICAL INTERVENTION DONE TO RETRIEVE THE FALLEN DEVICE. THERE ARE ALSO NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394507 EVIS EXERA III DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q190V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MAJ-2315