BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORNUS ES

    MDR report key: 25011483 · Received April 28, 2026

    Report

    Report Number
    3003775027-2026-00092
    Event Type
    Injury
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ASAHI INTECC CO., LTD.
    Product Code
    FGE
    PMA / PMN Number
    K241801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. AS THE INFORMATION IN THIS REPORT WAS ENTIRELY BASED ON LITERATURE, WHICH DID NOT PROVIDE SUCH DETAILED DEVICE INFORMATION AS LOT NUMBER OR UNIQUE DEVICE IDENTIFIER (UDI), NO OTHER INFORMATION THAN THE BRAND NAME COULD BE OBTAINED. DEVICE EVALUATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED DEVICES WERE NOT RETURNED. 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. MULTIPLE ASAHI AND NON-ASAHI PRODUCTS WERE USED IN THIS STUDY; HOWEVER, HOW EACH MENTIONED PRODUCT HAD CAUSED OR CONTRIBUTED TO ADVERSE EVENTS WAS UNABLE TO BE DETERMINED BASED ON THE LIMITED WRITTEN INFORMATION. REFERRING TO KNOWN SIMILAR EVENTS, IT WAS PRESUMED THAT PATIENT ANATOMY AND OPERATORS' TECHNIQUE WERE MOST LIKELY ASSOCIATED WITH SUCH ADVERSE EVENTS AS PANCREATITIS AND BLEEDING THAT HAD REPORTEDLY OCCURRED DURING THIS STUDY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ DO NOT MANIPULATE THIS DEVICE IF IT IS NOT CLEARLY VISIBLE UNDER NUOROSCOPY. [PRECAUTIONS] ~ WHEN MANIPULATING THIS DEVICE, MONITOR ITS MOVEMENT UNDER FLUOROSCOPY AND IN THE ENDOSCOPIC VIEW. ~ IF THE DEVICE MEETS INCREASED RESISTANCE DURING DILATION, ROLATE THE HAND GRIP COUNTERCLOCKWISE TO MOVE THE DEVICE BACKWARD. THEN, TRY DILATING AGAIN BY ROTATING THE HANDGRIP CLOCKWISE. [MALFUNCTION AND ADVERSE EFFECTS] 2. ADVERSE EVENTS ~ PANCREATITIS ~ HEMORRHAGE ~ BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LITERATURE THAT AN ASAHI TORNUS ES ENDOSCOPIC DILATOR MIGHT HAVE CONTRIBUTED TO PANCREATITIS AND/OR BLEEDING. PUBLICATION: GASTROINTESTINAL ENDOSCOPY, 2026 MAR 3: S0016-5107(26)00156-2. TITLE: USE OF A SCREW DILATOR FOR PANCREATICOBILIARY DISEASE. EXCERPT: METHODS: THIS RETROSPECTIVE STUDY EVALUATED A CONSECUTIVE SERIES OF ALL PATIENTS WHO UNDERWENT THERAPEUTIC EUS OR ERCP WITH USE OF THE TORNUS ES SCREW DILATOR BETWEEN JUNE 2025 AND JANUARY 2026 AT A SINGLE TERTIARY CARE CENTER. PROCEDURES WERE PERFORMED BY A SINGLE EXPERIENCED ENDOSCOPIST (T.H.B., PROFESSOR WITH >25 YEARS OF THERAPEUTIC EUS/ERCP EXPERIENCE). NO EXCLUSION CRITERIA WERE APPLIED. DATA WERE COLLECTED FROM ELECTRONIC MEDICAL RECORDS AND OPERATIVE REPORTS. TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL STENT PLACEMENT ACROSS THE DILATED TRACT/DUCT. AES WERE GRADED PER THE ASGE AGREE CLASSIFICATION. [PROCEDURAL TECHNIQUE]: AFTER GUIDEWIRE ACCESS (0.025" VISIGLIDE, OLYMPUS), ATTEMPTS WERE MADE TO PASS A 4-MM BALLOON DILATING CATHETER (HURRICANE RX, BOSTON SCIENTIFIC). WHEN THIS FAILED, THE SCREW DILATOR WAS ADVANCED OVER THE WIRE UNTIL RESISTANCE WAS ACHIEVED, THEN ROTATED CLOCKWISE TO THE DESIRED LOCATION AS PREVIOUSLY DESCRIBED. THE DEVICE WAS WITHDRAWN BY COUNTERCLOCKWISE ROTATION. RESULTS: TWENTY PATIENTS UNDERWENT 21 PROCEDURES. MEAN AGE WAS 62 ?} 13 YEARS, 45% WERE FEMALE, AND MEAN ASA WAS 3.1 ?} 0.4. SIX PATIENTS (30%) HAD SURGICALLY ALTERED ANATOMY. EIGHT PROCEDURES (38%) WERE ERCP AND 13 (62%) WERE THERAPEUTIC EUS. TECHNICAL SUCCESS WAS 95% (20/21). AES OCCURRED IN 8/20 PATIENTS (40%). THREE WERE GRADE II (PANCREATITIS), FOUR WERE GRADE IIIA (DUODENAL LEAK, STENT MIGRATION, BLEEDING, AND STENT-RELATED GASTRIC OUTLET OBSTRUCTION), AND ONE WAS GRADE V. DISCUSSION: ALL EIGHT AES WERE TYPICAL COMPLICATIONS OF THERAPEUTIC EUS AND ERCP RELATED TO PROCEDURAL COMPLEXITY AND PATIENT DISEASE SEVERITY RATHER THAN DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498327 TORNUS ES BILIARY CATHETER AND ACCESSORIES FGE ASAHI INTECC CO., LTD. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other