BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT ESO TTS FC 20 DM 12CM 180

    MDR report key: 17413676 · Received July 28, 2023

    Report

    Report Number
    2429304-2023-00249
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    June 3, 2021
    Report Date
    July 28, 2023
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    UDI-DI
    08806367088529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE HANAROSTENT WAS IMPLANTED IN THE ESOPHAGUS OF THE PATIENT, MIGRATED INTO THE STOMACH AND CAUSED A PNEUMOPERITONEUM. DR. (B)(6) HAD ALSO FOUND A PERFORATION IN THE STOMACH AND HE CLOSED IT OFF WITH TWO CLIPS. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946017 HANAROSTENT ESO TTS FC 20 DM 12CM 180 PROSTHESIS, ESOPHAGEAL ESW M.I.TECH CO., LTD. ECBA-20-120-180 20060968 08806367088529

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention