BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS DUODENOVIDEOSCOPE

    MDR report key: 18664150 · Received February 7, 2024

    Report

    Report Number
    9610595-2024-02686
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    April 17, 2023
    Report Date
    April 15, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, A 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 MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "GUIDE WIRE SELECTION (STRAIGHT VS ANGLED) IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING A NORMAL CONTRAST CATHETER PERFORMED BY A TRAINEE: A SINGLE-CENTER PROSPECTIVE RANDOMIZED CONTROLLED CROSS-OVER STUDY". LITERATURE SUMMARY: INTRODUCTION: WIRE-GUIDED CANNULATION (WGC) DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS A SELECTIVE BILIARY CANNULATION TECHNIQUE AIMED AT IMPROVING THE SUCCESSFUL SELECTIVE BILIARY CANNULATION RATE AND REDUCING THE RATE OF POST-ERCP PANCREATITIS (PEP) INCIDENCE. THIS STUDY AIMED TO EVALUATE THE EFFECTIVENESS OF ANGLED-TIP GUIDEWIRES (AGW) VS. STRAIGHT-TIP GUIDEWIRES (SGW) FOR BILIARY CANNULATION VIA WGC BY A TRAINEE. METHODS: WE CONDUCTED A PROSPECTIVE, SINGLE-CENTER, OPEN-LABELED, RANDOMIZED, AND CONTROLLED TRIAL. FIFTY-SEVEN PATIENTS WERE ENROLLED IN THIS STUDY AND ASSIGNED RANDOMLY TO TWO GROUPS (GROUP A TO S AND GROUP S TO A). IN THIS STUDY, WE STARTED SELECTIVE BILIARY CANNULATION VIA WGC WITH AN AGW OR AN SGW FOR 7 MIN. IF CANNULATION WAS UNSUCCESSFUL, THE OTHER GUIDEWIRE WAS USED, AND CANNULATION WAS CONTINUED FOR ANOTHER 7 MIN (CROSS-OVER METHOD). RESULTS: THE SELECTIVE BILIARY CANNULATION SUCCESS RATE OVER 14 MIN WAS SIGNIFICANTLY HIGHER WITH AN AGW COMPARED WITH AN SGW OVER 14 MIN (57.8% VS. 34.3%, P = 0.04) AND FOR THE SECOND 7-MIN SEGMENT (36.4% VS. 0%, P = 0.04). NO SIGNIFICANT DIFFERENCE WAS FOUND FOR ADVERSE EVENTS SUCH AS PANCREATITIS BETWEEN THE TWO GUIDEWIRES. CONCLUSIONS: OUR RESULTS SUGGEST THAT AN AGW IS RECOMMENDED FOR WGC PERFORMED BY A TRAINEE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PANCREATITIS (4). THE REPORT IS LINKED TO THE RELATED PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792200 EVIS DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. JF-240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ANGLED-TIP OR STRAIGHT-TIP (VISIGLIDE 2)| JF-240, DUODENOSCOPE| NON-OLYMPUS, DOUBLE-LUMEN INJECTION CATHETER| TJF260V, DUODENOSCOPE