BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT ESO TTS FC 20 DM 10CM 180

    MDR report key: 21990810 · Received May 8, 2025

    Report

    Report Number
    3008146331-2025-00002
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 9, 2025
    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 HOSPITAL ALSO SUBMITTED A REPORT UNDER MEDWATCH REFERENCE NO: 2429304-2025-00143. THE PRODUCT WAS NOT RETURNED, SO NO PHYSICAL EVALUATION WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH STENT PLACEMENT IN THE PYLORUS, THE STENT BROKE IN HALF WHEN PLACED IN THE PATIENT'S PYLORUS. THE SUPERIOR HALF OF STENT CAUSED AN OBSTRUCTION NEAR THE ILEUM AND WAS REMOVED ORALLY IN A SEPARATE PROCEDURE. THE OTHER HALF OF THE STENT PASSED INTO THE COLON AND WAS DEFECATED. THE PATIENT WILL LIKELY HAVE A FOLLOW UP PROCEDURE WHERE A COMPETITOR DEVICE WILL BE IMPLANTED. THERE WAS NO REPORTED FURTHER PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847499 HANAROSTENT ESO TTS FC 20 DM 10CM 180 HANAROSTENT ESO TTS FC 20 DM 10CM 180 ESW M.I.TECH CO., LTD. ECBA-20-100-180 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention