BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 18653070 · Received February 6, 2024

    Report

    Report Number
    9610595-2024-02578
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    September 28, 2023
    Report Date
    February 15, 2024
    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

    SINCE THE LITERATURE DESCRIBED ERCP WAS PERFORMED USING A "EVIS LUCERA DUODENOVIDEOSCOPE (JF-260V OR TJF-260V)", WE SELECTED "TJF-260V" AS A REPRESENTATIVE PRODUCT 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 MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "UTILITY OF COVERED SELF-EXPANDING METAL STENTS FOR BILIARY DRAINAGE DURING NEOADJUVANT CHEMOTHERAPY IN PATIENTS WITH BORDERLINE RESECTABLE PANCREATIC CANCER." THIS WAS A RETROSPECTIVE, SINGLE-CENTER, OBSERVATIONAL STUDY. FORTY CONSECUTIVE PATIENTS WITH BORDERLINE RESECTABLE PANCREATIC CANCER (BRPC) WHO UNDERWENT ENDOSCOPIC BILIARY STENTING (EBS) DURING NEOADJUVANT CHEMOTHERAPY AT HIROSHIMA UNIVERSITY HOSPITAL FROM JANUARY 2010 TO DECEMBER 2021 WERE ENROLLED. AMONG 40 PATIENTS, 19 PATIENTS HAD PLASTIC STENTS (PS GROUP), AND THE OTHER 21 HAD COVERED SELF-EXPANDING METAL STENTS (CSEMSS GROUP). IN THE PS GROUP, TWO PATIENTS IN WHOM METASTASIS WAS DETECTED DURING SURGERY AND COULD NOT RECEIVE CURATIVE SURGERY WERE INCLUDED. ERCP WAS PERFORMED USING A EVIS LUCERA DUODENOVIDEOSCOPE (JF-260V OR TJF-260V). TREATMENT OUTCOMES AND POSTOPERATIVE COMPLICATIONS WERE COMPARED BETWEEN BOTH GROUPS. PS GROUP - POSTOPERATIVE COMPLICATION PANCREATIC FISTULA - 2 PATIENTS CHOLANGITIS - 1 PATIENT DELAYED GASTRIC EMPTYING - 2 PATIENTS OTHER - 2 PATIENT CSEMS GROUP - POSTOPERATIVE COMPLICATION CHOLANGITIS - 2 PATIENTS DELAYED GASTRIC EMPTYING - 1 PATIENT DEATH - 1 PATIENT OTHER - 3 PATIENT NON-OCCLUSIVE CHOLANGITIS WAS RELIEVED BY INTRAVENOUS ADMINISTRATION OF ANTIBIOTICS. CHOLECYSTITIS WAS RELIEVED CONSERVATIVELY BY PERCUTANEOUS TRANSHEPATIC GALLBLADDER ASPIRATION AND INTRAVENOUS ADMINISTRATION OF ANTIBIOTICS. THIS REPORT IS RELATED TO PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463533 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention