BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA ULTRATHIN VIDEOSCOPE

    MDR report key: 18647888 · Received February 5, 2024

    Report

    Report Number
    9610595-2024-02503
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    February 9, 2023
    Report Date
    March 19, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FBN
    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

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR. B5 HAS BEEN UPDATED ACCORDINGLY. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR, THERE IS NO CHANGE TO THE PREVIOUSLY REPORTED LEGAL MANUFACTURER INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. DOI.ORG/10.1016/J.GIE.2023.02.005 PROVIDED FOR ADDITIONAL INFORMATION. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    THE AUTHOR REPORTED THAT THE EVENTS DESCRIBED IN THE ARTICLE WERE NOT CAUSED BY AN OLYMPUS PRODUCT.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE LITERATURE TITLED "INNOVATIVE METHOD FOR THE DIAGNOSIS OF BILE DUCT LESIONS USING A NOVEL TAPERED-TIP SHEATH SYSTEM TO FACILITATE BILIARY BIOPSIES." BACKGROUND AND AIMS: PATHOLOGIC EVALUATION OF BILE DUCT LESIONS IS CRUCIAL FOR A DEFINITIVE DIAGNOSIS AND DETERMINATION OF AN APPROPRIATE THERAPEUTIC STRATEGY; HOWEVER, CURRENT METHODS ARE LIMITED BY SEVERAL CHALLENGES. THIS STUDY EVALUATED THE IMPACT OF A NOVEL TAPERED-TIP SHEATH SYSTEM ON BILIARY STRICTURE DIAGNOSIS. METHODS: THIS OBSERVATIONAL STUDY EVALUATED 47 CONSECUTIVE PATIENTS WHO UNDERWENT TRANSPAPILLARY BILIARY STRICTURE BIOPSY USING THE NOVEL TAPERED-TIP SHEATH SYSTEM FROM JULY 2020 TO MARCH 2022 COMPARED WITH 51 HISTORICAL CONTROL SUBJECTS UNDERGOING CONVENTIONAL BIOPSIES. TECHNICAL SUCCESS RATE, TOTAL BIOPSY TIME, NUMBER OF BIOPSY SPECIMENS, ADEQUATE TISSUE SAMPLING RATE, ADVERSE EVENTS, AND DIAGNOSTIC PERFORMANCE FOR BILIARY STRICTURES WERE ASSESSED. RESULTS: THE TECHNICAL SUCCESS RATE WAS FAVORABLE IN BOTH GROUPS, SHOWING NO SIGNIFICANT DIFFERENCE (97.9% [46 OF 47] VS 88.2% [45 OF 51], P Z .114). HOWEVER, THE TOTAL BIOPSY TIME WAS SIGNIFICANTLY SHORTER IN THE NOVEL SYSTEM GROUP (3.7 VS 7.7 MINUTES, P < .001). THE NUMBER OF BIOPSY SPECIMENS DID NOT DIFFER BETWEEN THE GROUPS; HOWEVER, THE NOVEL SYSTEM GROUP HAD SIGNIFICANTLY MORE CASES IN WHICH 3 TISSUE SAMPLES COULD BE OBTAINED (71.7% [33 OF 46] VS 51.1% [23 OF 45], P Z .043), A HIGHER ADEQUATE TISSUE SAMPLING RATE (88.2% VS 66.4%, P < .001), AND FEWER ADVERSE EVENTS (6.4% VS 21.6%, P Z .043). ALTHOUGH THE DIAGNOSTIC SPECIFICITY OF BOTH GROUPS WAS 100%, THE NOVEL SYSTEM GROUP HAD SIGNIFICANTLY HIGHER DIAGNOSTIC SENSITIVITY AND ACCURACY (82.1% VS 50% [P Z .004] AND 84.8% VS 55.5% [P Z .005], RESPECTIVELY). CONCLUSIONS: THE NOVEL TAPERED-TIP SHEATH SYSTEM IS A PROMISING TOOL FOR BILIARY STRICTURE DIAGNOSIS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ACUTE PANCREATITIS (MILD=10, MODERATE=1, SEVERE=2) CHOLANGITIS (1) THERE ARE THREE RELATED PATIENT IDENTIFIERS: (B)(6) :TJF-260V (EVIS LUCERA DUODENOVIDEOSCOPE) (B)(6) :CHF-B260 (EVIS LUCERA ULTRATHIN VIDEOSCOPE) (B)(6) :UM-G20-29R (ULTRASONIC PROBE) THIS MEDWATCH IS FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503376 EVIS LUCERA ULTRATHIN VIDEOSCOPE CHOLEDOCHO FIBERSCOPE FBN AIZU OLYMPUS CO., LTD. CHF-B260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other TJF-260V (EVIS LUCERA DUODENOVIDEOSCOPE)| UM-G20-29R (ULTRASONIC PROBE)