BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT ESO TTS FC 20 DM 15CM 230

    MDR report key: 17412986 · Received July 28, 2023

    Report

    Report Number
    2429304-2023-00248
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 12, 2021
    Report Date
    July 28, 2023
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    UDI-DI
    08806367088598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THE ESOPHAGEAL HANAROSTENT WAS USED OFF LABEL AND PLACED IN THE PATIENT'S UPPER DUODENUM. IT WAS IN THE PATIENT FOR A PERIOD OF TIME AND THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WENT TO THE EMERGENCY ROOM. IT WAS FOUND THROUGH A SCAN THAT THE DEVICE BECAME DISLODGED AND BROKE IN HALF. THE PATIENT WAS TAKEN FOR SURGERY TO REMOVE THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317369 HANAROSTENT ESO TTS FC 20 DM 15CM 230 PROSTHESIS, ESOPHAGEAL ESW M.I.TECH CO., LTD. ECBA-20-150-230 08806367088598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention