BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA

    MDR report key: 21303669 · Received February 4, 2025

    Report

    Report Number
    9614641-2025-00109
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 4, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    ODD
    UDI-DI
    04953170043765
    PMA / PMN Number
    K950729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARATIVE STUDY OF THERAPEUTIC OUTCOMES IN PATIENTS WHO DEVELOPED HEPATOLITHIASIS AFTER HEPATICOJEJUNOSTOMY: BALLOON-ASSISTED ENTEROSCOPIC APPROACH VERSUS PERCUTANEOUS TRANSHEPATIC APPROACH." BACKGROUND: THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WHO UNDERWENT HEPATICOJEJUNOSTOMY (HJS) IS CHALLENGING. IN THIS STUDY, WE AIMED TO CLARIFY THE THERAPEUTIC OUTCOMES OF DOUBLE BALLOON ENTEROSCOPY (DBE) AND PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) FOR HEPATOLITHIASIS AFTER HJS. METHODS: PATIENTS WHO UNDERWENT DBE OR PTBD FOR HEPATOLITHIASIS AFTER HJS AT HIROSHIMA UNIVERSITY HOSPITAL WERE ENROLLED, AND TREATMENT OUTCOMES AND RECURRENCE WERE COMPARED. RESULTS: FORTY-EIGHT OF THE 84 ELIGIBLE PATIENTS UNDERWENT DBE, WITH THE HJS SITE REACHED IN 42 PATIENTS (87.5%; DBE GROUP). FORTY-ONE PATIENTS UNDERWENT PTBD (PTBD GROUP). THERE WERE NO DIFFERENCES IN THE CLINICAL CHARACTERISTICS AND STONE-RELATED FACTORS, INCLUDING LOCALIZATION, MAXIMUM DIAMETER, AND QUANTITY, BETWEEN BOTH GROUPS. THE COMPLETE STONE REMOVAL RATES IN THE DBE AND PTBD GROUPS WERE 85.7% AND 90.2%, RESPECTIVELY. THE DBE GROUP HAD A SIGNIFICANTLY SHORTER MEDIAN LENGTH OF HOSPITAL STAY THAN THE PTBD GROUP (6 VS. 21 DAYS, P < 0.001). DURING A MEDIAN FOLLOW-UP OF 45 MONTHS, STONE RECURRENCE WAS OBSERVED IN 22 (32.8%) PATIENTS. THE CUMULATIVE RECURRENCE RATES AT 1, 3, 5, AND 10 YEARS WERE 13.1%, 31.8%, 34.9%, AND 52.7%, RESPECTIVELY. THE STONE RECURRENCE RATES OF THE DBE AND PTBD GROUPS WERE NOT SIGNIFICANTLY DIFFERENT (28.6% VS.37.5%). MULTIVARIATE ANALYSIS REVEALED A STONE DIAMETER > 8 MM (HAZARD RATIO, 2.602; P = 0.026) AND AGE = 70 YEARS (HAZARD RATIO, 3.077; P = 0.017) AS INDEPENDENT RISK FACTORS FOR STONE RECURRENCE. CONCLUSIONS: DBE SHOWED OUTCOMES COMPARABLE TO THOSE OF PTBD IN THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WHO UNDERWENT HJS. ALTHOUGH REACHING THE HJS SITE IS DIFFICULT IN SOME CASES, TREATMENT CAN BE COMPLETED WITHIN A SHORT PERIOD WITH DBE; THEREFORE, IT COULD BE THE FIRST CHOICE OF TREATMENT FOR HEPATOLITHIASIS AFTER HJS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MILD ACUTE CHOLANGITIS REQUIRING ANTIBIOTIC TREATMENT = 6 PATIENTS (DBE GROUP), MILD ACUTE CHOLANGITIS REQUIRING ANTIBIOTIC TREATMENT = 12 PATIENTS (PTBD GROUP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245868 CANNULA CANNULA ODD AOMORI OLYMPUS CO., LTD. PR-110Q-1 04953170043765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention .025 INCH GUIDEWIRE| 6-10 MM BALLOON DILATION CATHETER| BASKET CATHETER| ELECTROHYDRAULIC LITHOTRIPSY SYSTEM| ENDOSCOPE| ENDOSCOPIC NASOBILIARY DRAINAGE CATHETER| MECHANICAL LITHOTRIPTER| RETRIEVAL BALLOON CATHETER