BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 18346246 · Received December 18, 2023

    Report

    Report Number
    9610595-2023-19752
    Event Type
    Death
    Date Received
    December 18, 2023
    Date of Event
    June 28, 2023
    Report Date
    January 5, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K220587
    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. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED " STANDARD DUODENOSCOPE (TJF-200, JF-240, JF-260V, OR TJF-260V)", WE SELECTED "TJF-200, JF-240, JF-260V" AS REPRESENTATIVE PRODUCTS. SINCE THE LITERATURE DESCRIBED "GUIDEWIRE (.025-INCH VISIGLIDE2)", WE SELECTED "G-260-2545A" AS A REPRESENTATIVE PRODUCT. THE PRODUCT WAS UNKNOWN BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. 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.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " UTILITY OF BILATERAL INTRADUCTAL PLASTIC STENT FOR MALIGNANT HILAR BILIARY OBSTRUCTION COMPARED WITH BILATERAL SELF-EXPANDABLE METAL STENT: A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS". THIS RETROSPECTIVE STUDY EVALUATED THE LONG-TERM EFFICACY AND SAFETY OF BILATERAL INTRADUCTAL PLASTIC STENT (IS) PLACEMENT COMPARED WITH BILATERAL SELF-EXPANDABLE METAL STENT (SEMS) PLACEMENT FOR UMHBO USING A PROPENSITY SCORE¿MATCHED COHORT ANALYSIS. A TOTAL OF 130 PATIENTS WERE INCLUDED IN THE ANALYSIS. THE MEDIAN INITIAL ENDOSCOPIC PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE IS GROUP (23 VS 49 MINUTES, P < .01). ERI WAS PERFORMED ON 20 AND 19 PATIENTS IN THE IS AND SEMS GROUPS, RESPECTIVELY. THE MEDIAN ERI PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE IS GROUP (22 VS 35 MINUTES, P = .04). CLINICAL SUCCESS WAS ACHIEVED IN 37 OF 38 CASES (97%) IN THE IS GROUP AND IN ALL 37 SUCCESSFUL BILATERAL SEMS PLACEMENT CASES (100%). THE MULTIVARIATE ANALYSIS SHOWED THAT PERFORMANCE STATUS (0-1) (HAZARD RATIO, .45; 95% CONFIDENCE INTERVAL, .25-.82; P < .01) WAS THE ONLY SIGNIFICANT RELATED FACTOR FOR OS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS POST-ERCP PANCREATITIS -1 PATIENT CHOLECYSTITIS-7 PATIENTS ERI FAILURE- 4 PATIENTS (NOT RELEVANT TO OLYMPUS DEVICES) DEATH- (UNKNOWN NUMBER OF PATIENTS) ALL CHOLECYSTITIS CASES WERE SUCCESSFULLY MANAGED WITH PERCUTANEOUS DRAINAGE, WHEREAS THE POST-ERCP PANCREATITIS CASE WAS SUCCESSFULLY MANAGED CONSERVATIVELY. THIS LITERATURE ARTICLE REQUIRES 7 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): TJF-200 (PANCREATITIS AND CHOLECYSTITIS) (B)(6): JF-240 (PANCREATITIS AND CHOLECYSTITIS) (B)(6): JF-260V (PANCREATITIS AND CHOLECYSTITIS) (B)(6): TJF-200 (DEATH EVENT) (B)(6): JF-240 (DEATH EVENT) (B)(6): JF-260V (DEATH EVENT) (B)(6): G-260-2545A (ALL EVENTS) THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982969 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. JF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D