BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 17468937 · Received August 7, 2023

    Report

    Report Number
    9610595-2023-11219
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    June 28, 2021
    Report Date
    September 22, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR AS REFLECTED IN B5.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "USEFULNESS OF THE NOVEL SNARE-OVER-THE-GUIDEWIRE METHOD FOR TRANSPAPILLARY PLASTIC STENT REPLACEMENT (WITH VIDEO)". LITERATURE SUMMARY: THIS SINGLE-CENTER RETROSPECTIVE STUDY AIMED TO COMPARE THE USEFULNESS OF THE TWO METHODS: THE SNARE-OVER-THE-GUIDEWIRE (SOG) METHOD AND THE SIDE-OF-STENT (SOS) METHOD. A TOTAL OF 244 PATIENTS WERE INCLUDED (61 PATIENTS IN SOG GROUP AND 183 PATIENTS IN SOS GROUP). IN THE SOS GROUP, THE PERCENTAGE OF STRAIGHT-TYPE PSS WAS 30.0%, WHILE IN THE SOG GROUP, IT WAS 100.0% (P < 0.001). THE PROCEDURAL SUCCESS RATE IN THE SOG GROUP WAS SIGNIFICANTLY HIGHER THAN THAT IN THE SOS GROUP (90.2% VS. 77.1%, P = 0.026). THE TIME REQUIRED FOR PS REMOVAL (SECONDS) WAS SIGNIFICANTLY SHORTER IN THE SOG GROUP THAN IN THE SOS GROUP (306 S VS. 375 S, P = 0.012). MULTIVARIATE ANALYSIS ALSO SHOWED THAT THE SOS METHOD (ODDS RATIO (OR) 3.64, 95% CONFIDENCE INTERVAL (CI) 1.48¿10.46, P = 0.0038) AND THE PRESENCE OF PROXIMAL BILIARY STENOSIS (OR 5.08, 95% CI 2.37¿11.21, P < 0.0001). THE SOG METHOD MAY BE A VERY USEFUL PROCEDURE FOR PS PLACEMENT WITH POSSIBLE RE-INTERVENTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS POST-PROCEDURE PANCREATITIS (1) THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE AUTHOR HAS CONFIRMED THAT THE ADVERSE EVENTS WERE NOT RELATED TO THE OLYMPUS DEVICE AND THAT THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663278 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other