BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHOLEDOCHO VIDEOSCOPE

    MDR report key: 9952454 · Received April 13, 2020

    Report

    Report Number
    8010047-2020-02165
    Event Type
    Death
    Date Received
    April 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBN
    PMA / PMN Number
    K081456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "RISK FACTORS AND CONSEQUENCES OF CONVERSION TO OPEN SURGERY IN LAPAROSCOPIC COMMON BILE DUCT EXPLORATION". THE LITERATURE REPORTED THE RESULT OF 644 CASES OF THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION PROCEDURES USING AN OLYMPUS MODEL CHF-V, FG-24X-1 BETWEEN 2011 AND 2017. IN THE SUBJECT PROCEDURES, 2 CASES OF "MORTALITY" AND 1 CASE OF "READMISSION WITHIN 30 DAYS", 3 CASES OF "REOPERATION" REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF THE ACCIDENTAL SYMPTOMS KNOWN AND THE NUMBER OF OLYMPUS DEVICES USED FOR PROCEDURE, OMSC IS SUBMITTING 6 MEDICAL DEVICE REPORTS. THIS IS 1 OF 6 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415808 CHOLEDOCHO VIDEOSCOPE CHOLEDOCO VIDEOSCOPE FBN OLYMPUS MEDICAL SYSTEMS CORP. CHF-V

    Patients

    Seq Age Sex Outcome Treatment
    1 Death