BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23775589 · Received December 11, 2025

    Report

    Report Number
    3008146331-2025-00005
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 1, 2024
    Report Date
    February 13, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    UDI-DI
    08806367088529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE HOSPITAL ALSO SUBMITTED A REPORT (EMDR-(B)(4), REFERENCE NO: (B)(4). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT IN A DUODENAL PROCEDURE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE DISTRIBUTOR ALSO SUBMITTED A REPORT REFERENCE NO: (B)(4). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE OFF-LABEL USE OF AN ESOPHASEAL STENT IN A DUODENAL PROCEDURE. 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

    IT WAS REPORTED THAT DURING A THERAPEUTIC STENT REMOVAL FOR A DUODENAL STRICTURE, THE SUSPECT DEVICE BROKE IN HALF. THE PIECES WERE RETRIEVED. THE ISSUE DATE WAS MENTIONED TO BE (B)(6) 2024. THE DEVICE, ESPHAGEAL STENT, WAS PLACED IN THE DUODENUM OF THE PATIENT. THE PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2025. A CT SCAN WAS COMPLETED AND IT WAS FOUND THAT THE IMPLANT HAD BROKEN INTO TWO PIECES, RESULTING IN SURGERY TO REMEDY THE ISSUE. NO SPECIFIC TIME WAS MENTIONED WHEN THE STENT HAD SPLIT IN 2 PIECES.

    Description of Event or Problem · 0

    OLYMPUS SALES REPRESENTATIVE (B)(4) REPORTED THE EVENT ON BEHALF OF THE TREATING PHYSICIAN, DOCTOR (B)(6). ACCORDING TO THE REPORT, AN ESOPHAGEAL STENT WAS IMPLANTED IN THE PATIENT'S DUODENUM IN (B)(6) 2024. THE PATIENT RETURNED TO THE HOSPITAL IN (B)(6) 2025, AT WHICH TIME A CT SCAN REVEALED THAT THE IMPLANTED STENT HAD FRACTURED INTO TWO PIECES, RESULTING IN SURGERY TO REMEDY THE ISSUE. THE EXACT TIME POINT WHEN THE STENT SPLIT INTO TWO PIECES WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775475 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-100-230 24101248 08806367088529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention