BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNUS ES

    MDR report key: 21782668 · Received April 6, 2025

    Report

    Report Number
    3003775027-2025-00098
    Event Type
    Injury
    Date Received
    April 6, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    FGE
    PMA / PMN Number
    K241801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE NOT RETURNED FROM THE USER FACILITY. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. AS THERE WERE NO DETAILED DESCRIPTIONS IN THE LITERATURE ABOUT HOW THE ASAHI TORNUS ES ENDOSCOPIC DILATOR WAS INVOLVED WITH THE REPORTED EUS-BD, THE CAUSE OF THE REPORTED ADVERSE EVENT OR HOW WHICH DEVICES WERE INVOLVED COULD NOT BE IDENTIFIED WITH THE LITERATURE. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND OPERATOR'S TECHNIQUE WERE MOST LIKELY ASSOCIATED WITH SUCH ADVERSE EVENTS AS BILE LEAKAGE AND BLEEDING THAT HAD REPORTEDLY OCCURRED DURING THIS STUDY. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE INSTRUCTIONS FOR USE (IFU) STATES: [PRECAUTIONS] ~ WHEN MANIPULATING THIS DEVICE, MONITOR ITS MOVEMENT UNDER FLUOROSCOPY AND IN THE ENDOSCOPIC VIEW. [MALFUNCTION AND ADVERSE EFFECTS] ~ BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT ASAHI TORNUS ES ENDOSCOPIC DILATOR MIGHT HAVE CAUSED OR CONTRIBUTED TO BILE LEAKAGE AND BLEEDING. PUBLICATION: EXPERIMENTAL AND THERAPEUTIC MEDICINE 29: 53, 2025 TITLE: SELECTION METHODS FOR ENDOSCOPIC ULTRASOUND-GUIDED BILIARY DRAINAGE CASES THAT ARE APPROPRIATE FOR BEGINNERS EXCERPT: MATERIALS AND METHODS [STUDY DESIGN, PATIENTS, AND ETHICS.] THIS WAS A RETROSPECTIVE STUDY THAT INVESTIGATED METHODS FOR SELECTING MBO CASES THAT ARE SUITABLE FOR EUS-BD BEGINNERS. THIS STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF FUKUSHIMA MEDICAL UNIVERSITY (APPROVAL NUMBER: REC (B)(4). PATIENTS WITH HISTOLOGICALLY DIAGNOSED MBO WHO UNDERWENT EUS-BD AT FUKUSHIMA MEDICAL UNIVERSITY BETWEEN MARCH 2005 AND JUNE 2024 WERE ENROLLED IN THIS STUDY. [EUS-BD PROCEDURES.] THE GUIDEWIRE USED WAS A 0.018 FIELDER 18, 0.025 VISIGLIDE, VISIGLIDE 2 (OLYMPUS MEDICAL SYSTEMS), 0.025 OR 0.035 JAGWIRE, OR 0.025 ENDOSELECTOR (BOSTON SCIENTIFIC JAPAN). THE DILATOR USED WAS A 6FR CYSTO-GASTRO-SET (ENDO-FLEX GMBH, VOERDE, GERMANY), AN ES DILATOR (ZEON MEDICAL CO., TOKYO, JAPAN), AN MTW ERCP TAPERED CATHETER (MTW ENDOSKOPIE, WESEL, GERMANY), A TORNUS ES (OLYMPUS MEDICAL SYSTEMS), OR A 4 MM HURRICANE RX BILIARY BALLOON DALATION CATHETER (BOSTON SCIENTIFIC JAPAN). RESULTS [PARTICIPANTS.] EUS-BD WAS ATTEMPTED IN 52 PATIENTS WITH MBO. AMONG THESE PATIENTS, 45 UNDERWENT EUS-BD PERFORMED BY BEGINNERS. THREE PATIENTS WITH A HISTORY OF PANCREATICODUODENOTECTOMY AND BILIOJEJUNOSTOMY WERE EXCLUDED FROM THIS STUDY BECAUSE THEY UNDERWENT EUS-BD VIA A FORWARD-VIEWING ECHOENDOSCOPE. OVERALL, 42 PATIENTS WHO UNDERWENT EUS-BD PERFORMED BY BEGINNERS WITH THE USE OF A SIDE-VIEW ECHOENDOSCOPE WERE INCLUDED IN THIS STUDY. [SUMMARY OF PATIENT CHARACTERISTICS AND EUS-BD PROCEDURES.] THE PATIENT CHARACTERISTICS AND EUS-BD PROCEDURES PERFORMED BY BEGINNERS ARE SHOWN IN TABLE I. THE MEAN AGE WAS 71.7+-9.4 YEARS. TWENTY-SEVEN (64.3%) PATIENTS WERE MALE. THE ADVERSE EVENTS WERE BILE LEAKAGE (N=1) AND BLEEDING (N=1). TABLE I. SUMMARY OF PATIENT CHARACTERISTICS (N=42) AND EUS-BD PERFORMED BY BEGINNERS. [PARAMETERS---VALUE] MEAN AGE +- SD, YEARS---71.7?}9.4 SEX, N (%) MALE---27 (64.3) FEMALE---15 (35.7) ADVERSE EVENTS, N (%)---2 (4.8) BILE LEAKAGE, N---1 BLEEDING, N---1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736389 TORNUS ES BILIARY CATHETER AND ACCESSORIES FGE ASAHI INTECC CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other