BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23786864 · Received December 12, 2025

    Report

    Report Number
    3008146331-2025-00009
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    July 12, 2021
    Report Date
    February 13, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS INTENDED TO CORRECT THE CODING TERMS THAT WERE EITHER INCORRECTLY ENTERED OR OMITTED IN THE PREVIOUS REPORT. BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE, WHICH THE ESOPHAGEAL STENT WAS PLACED IN DUODEUM. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE DISTRIBUTOR ALSO SUBMITTED A REPORT (REFERENCE NO:2429304-2023-00248). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE, WHICH THE ESOPHAGEAL STENT WAS PLACED IN DUODEUM. GIVEN THIS OFF-LABEL USE, WE ASSUME THAT THE STENT FRACTURE OCCURRED DUE TO THIS INAPPROPRIATE APPLICATION OF THE PRODUCT. CONSEQUENTLY, IT IS NOT POSSIBLE TO ANALYZE THE ROOT CAUSE BASE ON THE PRODUCT'S INTENDED USE. NO FURTHER INFORMATION IS EXPECTED. THE INITIAL MDR SUBMISSION WAS DELAYED BECAUSE M.I.TECH WAS NOT AWARE THAT DISTRIBUTORS HAD INDEPENDENTLY SUBMITTED MDRS, AS SEVERAL NOTIFICATIONS WERE SENT TO AN INACTIVE EMAIL ADDRESS AND NO INTERNAL PROCESS YET EXISTED TO ROUTINELY VERIFY DISTRIBUTOR-SUBMITTED REPORTS. THIS GAP HAS NOW BEEN ADDRESSED THROUGH OLYMPUS STAFF RETRAINING, INITIATION OF A CAPA, AND M.I.TECH'S IMPLEMENTATION OF A REGULAR REVIEW PROCESS TO ENSURE TIMELY IDENTIFICATION OF MDR-REPORTABLE EVENTS.

    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.

    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
    2758699 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-150-230 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention