BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23786863 · Received December 12, 2025

    Report

    Report Number
    3008146331-2025-00011
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    June 3, 2021
    Report Date
    February 13, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS AN INITIAL MDR BY THE MANUFACTURER. THE DISTRIBUTOR ALSO SUBMITTED A REPORT (REFERENCE NO:2429304-2025-00159). BASED ON THE DESCRIPTION, THIS CASE INVOLVES THE STENT ISSUE (STENT FRACTURE) OF AN ESOPHAGEAL STENT. AS THE PRODUCT CANNOT BE RETRIEVED, THE FOLLOW-UP 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 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 STENT ISSUE (STENT FRACTURE, MIGRATION) OF AN ESOPHASEAL STENT. AS THE PRODUCT CANNOT BE RETRIEVED, THE FOLLOW-UP REPORT WILL BE PREPARED BASED ON THEORETICAL ANALYSIS AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR).

    Description of Event or Problem · 0

    AREA SALESPERSON (B)(4) REPORTS THE HANAROSTENCE CAUSED PERFORATION IN THE STOMACH OF A PATIENT. THE CALLER HAD ANSWERED "NO" TO THE PAE QUESTION ON WAS THERE A DEATH, INJURY, OR INFECTION. AREA SALESPERSON (B)(4) REPORTS THE HANAROSTENCE WITH PART NUMBER ECBA-20-120-180 WITH LOT #20060968 WAS IMPLANTED TO THE ESOPHAGUS OF THE PATIENT AND IT HAD MIGRATED INTO THE STOMACH, THE STANCE IN TERM CAUSE A PNEUMOPERITONEUM. DR. (B)(6) HAD ALSO FOUND A PERFORATION IN THE STOMACH AND HE CLOSE IT OFF WITH TWO CLIPS.

    Description of Event or Problem · 0

    AREA SALESPERSON (B)(6) REPORTS THE HANAROSTENCE CAUSED PERFORATION IN THE STOMACH OF A PATIENT. THE CALLER HAD ANSWERED "NO" TO THE PAE QUESTION ON WAS THERE A DEATH, INJURY, OR INFECTION. AREA SALESPERSON (B)(6) REPORTS THE HANAROSTENCE WITH PART NUMBER ECBA-20-120-180 WITH LOT #20060968 WAS IMPLANTED TO THE ESOPHAGUS OF THE PATIENT AND IT HAD MIGRATED INTO THE STOMACH, THE STANCE IN TERM CAUSE A PNEUMOPERITONEUM. (B)(6) HAD ALSO FOUND A PERFORATION IN THE STOMACH AND HE CLOSE IT OFF WITH TWO CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758698 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-120-180 20060968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention