BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 19565908 · Received June 19, 2024

    Report

    Report Number
    9610595-2024-12306
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    January 2, 2024
    Report Date
    July 12, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170367311
    PMA / PMN Number
    K143153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED TJF-145, TJF-160VR, OR TJF-Q180V AS THE ENDOSCOPES USED IN THE PROCEDURES, OLYMPUS SELECTED TJF-160VR AND TJF-Q180V AS REPRESENTATIVE MODELS. THE EVALUATION OF THE EVENT IS ONGOING. ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH IS RELATED TO THE FOLLOWING PATIENT IDENTIFIERS: (B)(6).

    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 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 RECEIVED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF BILIARY STENTS IN MALIGNANT BILIARY STRICTURES." THIS RETROSPECTIVE STUDY WAS TO COMPARE THE EFFECTIVENESS OF SELF-EXPANDABLE METAL STENTS (SEMSS) AND PLASTIC STENTS (PSS) IN THE ENDOSCOPIC DRAINAGE OF MALIGNANT STRICTURES OF THE BILIARY TREE AND ITS SEQUELS FOR THE FUTURE OPTIMIZATION OF THIS TREATMENT METHOD. A TOTAL OF 618 PATIENTS WERE INCLUDED (456 IN THE PS GROUP AND 162 PATIENTS IN SEMS GROUP). IN THE PS GROUP, STRAIGHT STENTS EXHIBITED A LONGER MEDIAN PATENCY TIME THAN DPT STENTS (52 [21106] DAYS VS 34.5 [14¿73] DAYS; P = 0.001). A DECREASED MEDIAN STENT PATENCY TIME WAS OBSERVED IN THE PATIENTS WITH HIGH VS LOW OBSTRUCTION LEVEL (49 [20¿109] DAYS VS 66 [28¿136] DAYS; P = 0.003). MEDIAN (IQR) BILIRUBIN DROP WAS 37% (14%¿58%) IN THE SEMS GROUP AND 32% (9%¿53%) IN THE PS GROUP (P = 0.01). MOREOVER, THE PATIENTS IN THE SEMS GROUP SHOWED A CRP LEVEL DECREASE BY 10.5%, WHEREAS IN THE PS GROUP THE CRP LEVEL ROSE BY 17% (P = 0.02). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS ACUTE PANCREATITIS (36 CASES) LIVER ABSCESS (25 CASES) BLEEDING (24 CASES) PERFORATION (8 CASES) CHOLECYSTITIS (5 CASES) OTHER (21 CASES)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549971 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-Q180V 04953170367311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other BILIARY STENT