BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 17242946 · Received June 30, 2023

    Report

    Report Number
    9610595-2023-09591
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    November 1, 2022
    Report Date
    July 21, 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

    SINCE THE LITERATURE STATED "JF-260V, OR TJF-260V," OLYMPUS SELECTED "TJF-260V" AS A REPRESENTATIVE PRODUCT. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE HTTPS://DOI.ORG/10.1016/J.GIE.2022.10.038 PROVIDED 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 AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT. 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 EVENTS 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 "EFFECT OF URSODEOXYCHOLIC ACID AFTER SELF-EXPANDABLE METAL STENT PLACEMENT IN MALIGNANT DISTAL BILIARY OBSTRUCTION: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS". THIS MULTICENTER RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY OF URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH SELF-EXPANDABLE METALLIC STENT (SEMS) FOR MALIGNANT DISTAL BILIARY OBSTRUCTION (MDBO) USING A PROPENSITY SCORE¿MATCHED (PSM) COHORT ANALYSIS. A TOTAL OF 354 PATIENTS WERE INCLUDED (294 PATIENTS DID NOT RECEIVE UDCA AND 60 PATIENTS DID RECEIVE UDCA). IN THE PSM COHORT, THE SEMS OCCLUSION RATES IN THE CONTROL AND UDCA GROUPS WERE 5.5% AND 18.2% AT 3 MONTHS (P = .0732), 9.1% AND 36.4% AT 6 MONTHS (P = .0030), 14.5% AND 40.0% AT 12 MONTHS (P = .0049), AND 18.2% AND 41.8% AFTER THE COMPLETE PERIOD (P = .0119). BASED ON THE UNIVARIATE ANAL YSIS RESULTS, UDCA ADMINISTRATION (P Z .0429) AND 8-CM LONG SEMS (P = .13) WERE FURTHER ASSESSED BY MULTIVARIATE ANALYSIS. IN CONCLUSION, ADMINISTERING UDCA AFTER SEMS PLACEMENT IN PATIENTS WITH MDBO DID NOT SHOW EFFICACY FOR PROLONGING TRBO. PATIENTS RECEIVING UDCA FOR MORE THAN A MONTH MIGHT BE AT INCREASED RISK FOR SLUDGE OCCLUSION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS [CONTROL GROUP] (PANCREATITIS - 6 PATIENTS) MILD - 4 PATIENTS, MODERATE - 2 PATIENTS, CHOLECYSTITIS - 6 PATIENTS. [UDCA GROUP] (PANCREATITIS - 2 PATIENTS) MILD - 1 PATIENT, MODERATE - 1 PATIENT, CHOLECYSTITIS - 5 PATIENTS, LIVER ABSCESS - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) / TJF-200, (B)(6) / JF-240, (B)(6) / TJF-260V. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    OTHER RELEVANT PATIENT IDENTIFIERS AS FOLLOWS: (B)(6), (G-260-2545A); (B)(6), (SME-210P-10060); (B)(6), (TJF-200); (B)(6), (JF-240).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255118 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other