BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 24922621 · Received April 20, 2026

    Report

    Report Number
    3008146331-2026-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    ESW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS REQUESTED THE DISTRIBUTOR TO RETURN THE DEVICE FOR THE PRODUCT ANALYSIS, AND THE RETRIEVAL PROCESS IS CURRENTLY UNDERWAY. ONCE THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A CASE ANALYSIS REPORT WITH THE IDENTIFIED ROOT CAUSE.

    Description of Event or Problem · 0

    CUSTOMER CALLED TO REPORT A FRAGMENTED STENT. PRODUCT BROKE APART INSIDE THE PATIENT. DOCTOR WAS ABLE TO REMOVE THE PART SUCCESSFULLY. THE STENT WAS REMOVED FROM THE PATIENT TODAY (B)(6) 2026 SUCCESSFULLY. IMPLANT DATE WAS (B)(6) 2025. THE CUSTOMER IS GOING TO SEND THE ITEM IN FOR EVALUATION. CUSTOMER DOES NOT WANT A CREDIT NOR A REPLACEMENT. THEY JUST WANT TO HAVE THE STENT EVALUATED. I PROVIDED THE CUSTOMER THE CASE NUMBER. UNIT WILL BE SENT IN FOR EVALUATION. CUSTOMER REQUEST A REPORT FOR THE FINDINGS ON THE ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207834 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) ESW M.I.TECH CO., LTD. ECBA-20-080-230 24101311

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention