BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS AMERICA, INC.

    MDR report key: 145305 · Received December 30, 1997

    Report

    Report Number
    145305
    Event Type
    Injury
    Date Received
    December 30, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 11, 1997
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    20 Y/O FEMALE ADMITTED FOR AN ELECTIVE CHOLECYSTECTOMY. WHILE TRYING TO ATTEMPT A COMMON DUCT EXPLORATION, NOTED THE SCOPE WOULD NOT REACH THE DUCT STONE DUE TO POOR FLEXION. THE SCOPE EXHIBITED ONLY 70 DEGREE FLEXION INSTEAD OF 160 DEGREE FLEXION. THE LAPAROSCOPIC SURGERY WAS CONVERTED TO AN OPEN PROCEDURE TO REMOVE THE COMMON DUCT STONE. NO ADVERSE OUTCOME WAS NOTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AMERICA, INC. CHOLEODOCHOSCOPE/UTETEROSCOPE FGB OLYMPUS AMERICA, INC. URF-P2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention