BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    MDR report key: 18314737 · Received December 12, 2023

    Report

    Report Number
    9614641-2023-01892
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    August 7, 2020
    Report Date
    December 19, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170184031
    PMA / PMN Number
    K950166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERORAL CHOLANGIOSCOPY-GUIDED FORCEPS BIOPSY VERSUS FLUOROSCOPY-GUIDED FORCEPS BIOPSY FOR EXTRAHEPATIC BILIARY LESIONS". THE STUDY EVALUATED THE DIAGNOSTIC YIELD AND SAFETY OF FLUOROSCOPY-GUIDED FORCEPS BIOPSY (F-FB) FOR INDETERMINATE BILIARY LESIONS COMPARED WITH PERORAL CHOLANGIOSCOPY (POCS) AND POCS-GUIDED FORCEPS BIOPSY (POCS-FB) WHILE USING SIDEVIEWING DUODENOSCOPE (JF260V/TJF240V/TJF290V; OLYMPUS OPTICAL CO., LTD., TOKYO, JAPAN) WAS USED FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), 0.025-INCH HYDROPHILIC GUIDEWIRE (G-260-2545A; OLYMPUS OPTICAL CO., LTD. AND FB-45Q-1 (OLYMPUS OPTICAL CO., LTD.) BIOPSY FORCEPS. ACUTE PANCREATITIS - 9 PATIENTS. INFECTION (CHOLANGITIS) - 3 PATIENTS. PULMONARY DISORDER - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 5 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) :JF-260V. (B)(6) : TJF-240. (B)(6) :TJF-Q290V. (B)(6) :FB-45Q-1. (B)(6) :KD-V411M-0725. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) : KD-V411M-0725.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525689 SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME KNS AOMORI OLYMPUS CO., LTD. KD-V411M-0725 04953170184031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FB-45Q-1| JF-260V| TJF-240| TJF-Q290V