BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN)

    MDR report key: 23775593 · Received December 11, 2025

    Report

    Report Number
    3008146331-2025-00007
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 11, 2025
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.:2429304-2025-00242). 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

    SALES REP ALEXANDER REHNBERG CALLED IN REPORTING THAT THE DNJF-22-090-230 STENT WAS DEPLOYED INTO PATIENT'S DUODENUM, THE CUSTOMER PULLED BACK ON CATHETER TO REMOVE THE DEPLOYMENT CATHETER AND MET SOME RESISTANCE WHEN PULLING BACK BUT CONTINUED TO PULL AND THE STENT ENDED UP FRACTURING. CUSTOMER ATTEMPTED TO REMOVE FRACTURED STENT USING SOME GRASPING FORCEPS, BUT THE CUSTOMER WAS UNSUCCESSFUL AND A SECOND STENT WAS DEPLOYED. THE SECOND STENT, BOSTON SCIENTIFIC BRAND, WAS SUCCESSFULLY DEPLOYED. NO FURTHER ASSISTANCE REQUIRED FROM TAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775479 HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN) HANAROSTENT® LOWAX¿ DUODENUM/PYLORUS (NNN) MUM M.I.TECH CO., LTD. DNJF-22-090-230 25040467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention