BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23775586 · Received December 11, 2025

    Report

    Report Number
    3008146331-2025-00006
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    March 1, 2025
    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
    TX, 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 DISTRIBUTOR ALSO SUBMITTED A REPORT (REFERENCE NO: (B)(4)). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE STENT ISSUE (STENT FRACTURE) OF AN ESOPHASEAL STENT. WE ARE CURRENTLY CONFIRMING THROUGH THE DISTRIBUTOR WHETHER THE PRODUCT CAN BE RETRIEVED. IF THE PRODUCT BECOMES AVAILABLE, WE WILL PERFORM A PRODUCT ANALYSIS AND PREPARE THE REPORT BY IDENTIFYING THE MOST PROBABLE ROOT CAUSE. IF THE PRODUCT CANNOT BE RETRIEVED, THE REPORT WILL BE PREPARED BASED ON THEORETICAL ANALYSIS AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). 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.

    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 STENT ISSUE (STENT FRACTURE) OF AN ESOPHASEAL STENT. WE ARE CURRENTLY CONFIRMING THROUGH THE DISTRIBUTOR WHETHER THE PRODUCT CAN BE RETRIEVED. IF THE PRODUCT BECOMES AVAILABLE, WE WILL PERFORM A PRODUCT ANALYSIS AND PREPARE THE REPORT BY IDENTIFYING THE MOST PROBABLE ROOT CAUSE. IF THE PRODUCT CANNOT BE RETRIEVED, THE REPORT WILL BE PREPARED BASED ON THEORETICAL ANALYSIS AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). 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

    THE CUSTOMER (B)(6) REPORTED TO OLYMPUS REPRESENTATIVE (B)(6) THAT THE ECBA-20-100-180 HANARO STENT WAS PLACED IN THE PATIENT ON MARCH 1 AND FRACTURED AND BROKE APART IN THE PATIENT. THE DOCTOR RETRIEVED BOTH PIECES FROM THE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER (B)(6) REPORTED TO OLYMPUS REPRESENTATIVE (B)(4) THAT THE ECBA-20-100-180 HANARO STENT WAS PLACED IN THE PATIENT ON (B)(6) AND FRACTURED AND BROKE APART IN THE PATIENT. THE DOCTOR RETRIEVED BOTH PIECES FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2722185 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-100-180 UNKNOWN 08806367088529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention