BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    MDR report key: 23786866 · Received December 12, 2025

    Report

    Report Number
    3008146331-2025-00012
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Report Date
    December 12, 2025
    Manufacturer
    M.I.TECH CO., LTD.
    Product Code
    JCQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION OBTAINED FROM A PUBLISHED SCIENTIFIC LITERATURE ARTICLE DESCRIBING CLINICAL OUTCOMES AND ADVERSE EVENTS ASSOCIATED WITH ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) FOR BENIGN GASTRIC OUTLET OBSTRUCTION. THE PUBLICATION REPORTED EVENTS SUCH AS INTRAOPERATIVE GASTRIC BLEEDING, POSTOPERATIVE GASTRIC BLEEDING, AND RETROPERITONEAL HEMORRHAGE, ALL OF WHICH WERE RESOLVED WITH APPROPRIATE MEDICAL INTERVENTIONS. NO DEVICE WAS RETURNED TO M.I.TECH FOR EVALUATION, AND NO PATIENT-SPECIFIC OR DEVICE-SPECIFIC INFORMATION WAS AVAILABLE. BECAUSE THE REPORT IS DERIVED SOLELY FROM LITERATURE AND LACKS SPECIFIC INFORMATION LINKING AN M.I.TECH DEVICE TO THE DESCRIBED EVENTS, THE ROOT CAUSE CANNOT BE DETERMINED. THE INITIAL MDR SUBMISSION WAS DELAYED BECAUSE M.I.TECH WAS NOT AWARE OF THE DISTRIBUTOR-SUBMITTED MDRS AT THE TIME OF THE EVENTS, AS SEVERAL NOTIFICATIONS WERE SENT TO AN INACTIVE EMAIL ACCOUNT AND NO INTERNAL PROCEDURE YET EXISTED TO PERIODICALLY VERIFY INDEPENDENTLY SUBMITTED DISTRIBUTOR REPORTS; THIS ISSUE HAS SINCE BEEN ADDRESSED THROUGH OLYMPUS CAPA ACTIONS, STAFF RETRAINING, AND M.I.TECH'S ESTABLISHMENT OF A REGULAR REVIEW PROCESS.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY FOR BENIGN GASTRIC OUTLET OBSTRUCTION (GOO): A RETROSPECTIVE ANALYSIS OF PATIENTS AND OUTCOMES".LITERATURE SUMMARY BACKGROUND AND STUDY AIMS ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) HAS BEEN WELL UTILIZED IN TREATING MALIGNANT GASTRIC OUTLET OBSTRUCTIONS (GOO) GIVEN ITS EFFICACY AND LOWER RISK PROFILE COMPARED TO SURGERY.HOWEVER, ITS EFFICACY AND POTENTIAL FOR USE IN PATIENTS WITH BENIGN GOO WHO ARE POOR SURGICAL CANDIDATES IS NOT WELL DOCUMENTED.THE AIM OF THIS STUDY WAS TO EXAMINE THE ROLE OF EUS-GJ IN TREATMENT OF BENIGN GOO IN SELECT PATIENTS.PATIENTS AND METHODS THIS IS A SINGLE-CENTER, OPEN-LABEL, RETROSPECTIVE DESCRIPTIVE STUDY THAT INCLUDED ALL CONSECUTIVE PATIENTS UNDERGOING EUS-GJ TO TREAT BENIGN CAUSES OF GOO.DIRECT ANTEGRADE AND DIRECT RETROGRADE METHODS WERE UTILIZED.RESULTS A TOTAL OF 18 PATIENTS WERE INCLUDED, 38.9% FEMALE WITH AN AVERAGE AGE OF 63.3 YEARS.EXTRINSIC GOO WAS PRESENT IN (10 OF 18) 55.5% OF PATIENTS AND INTRINSIC ETIOLOGY WAS PRESENT IN (8 OF 18) 45.5% OF PATIENTS.TECHNICAL SUCCESS WAS ACHIEVED IN 100% (18 OF 18) PATIENTS AND CLINICAL SUCCESS WAS ACHIEVED IN 94% (17 OF 18) PATIENTS.IN TOTAL, 13 PATIENTS HAD FOLLOW-UP ENDOSCOPY, 2 PATIENTS WERE TREATED RELATIVELY RECENTLY IN TIME, 1 PATIENT WAS LOST TO FOLLOW-UP, AND 2 PATIENTS DIED OF OTHER CHRONIC ILLNESSES.STENTS REMAINED IN PLACE FOR A MEDIAN OF 286 DAYS (RANGE 88¿1444 DAYS).IN PATIENTS WHOSE STENTS WERE REMOVED, 75% (3 OF 4) HAD EXTRINSIC ETIOLOGIES OF GOO.CONCLUSIONS THIS STUDY REPORTS A FAVORABLE LONG-TERM PATENCY WITH EXCELLENT TECHNICAL AND CLINICAL SUCCESS OF EUS-GJ IN PATIENTS WITH BENIGN GOO.DESPITE THE LIMITATIONS OF SAMPLE SIZE AND RETROSPECTIVE NATURE, IT ADDS TO THE EXTREMELY LIMITED LITERATURE OF EUS-GJ IN MANAGEMENT OF PATIENTS WITH BENIGN GOO.THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE: INTRAOPERATIVE GASTRIC BLEEDING - RESOLVED WITH INTRAOPERATIVE EPINEPHRINE INJECTION POST-OPERATIVE GASTRIC BLEEDING - RESOLVED WITH CLIPPING AND EPINEPHRINE INJECTION POST-OPERATIVE RETROPERITONEAL HEMORRHAGE - RESOLVED WITH INTERVENTIONAL RADIOLOGY EMBOLIZATION A2: MEDIAN AGE IS 63 YEARS OLD.SINCE THE LITERATURE DESCRIBED THROUGH-THE-SCOPE (TTS) BALLOON, OLYMPUS SELECTED ECBA-18-060-180 AS A REPRESENTATIVE PRODUCT.THIS REPORT IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).THE DEVICE WAS NOT RETURNED.ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758701 HANAROSTENT?? ESOPHAGUS TTS (CCC) HANAROSTENT?? ESOPHAGUS TTS (CCC) JCQ M.I.TECH CO., LTD. ECBA-18-060-180 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention