BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 9796978 · Received March 6, 2020

    Report

    Report Number
    8010047-2020-01678
    Event Type
    Injury
    Date Received
    March 6, 2020
    Report Date
    March 6, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿NATURAL HISTORY OF ASYMPTOMATIC BILE DUCT STONES AND ASSOCIATION OF ENDOSCOPIC TREATMENT WITH CLINICAL OUTCOMES¿. THE LITERATURE REPORTED THE RESULT OF 77 CASES OF THE EARLY ENDOSCOPIC STONE REMOVAL OF ASYMPTOMATIC STONES PROCEDURES USING OLYMPUS DUODENOVIDEOSCOPE MODEL JF-260V OR TJF-260V OR NON-OLYMPUS ENDOSCOPE FROM JANUARY 2010 TO MARCH 2018. IN THE SUBJECT CASES, 3 CASE OF BLEEDING, 3 CASES OF ASPIRATION PNEUMONIA AND 1 CASE OF GASTROINTESTINAL PERFORATION OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCTS AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. THEREFORE, OMSC WILL SUBMIT 14 MEDICAL DEVICE REPORTS (MDR) DEPENDING ON THE TYPE OF DEVICE AND NUMBER OF ADVERSE EVENTS. THIS REPORT IS 9 OF 14 REPORTS FOR BLEEDING (2 OF 3) AT TJF-260V.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265139 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other