BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS SCOPE

    MDR report key: 135045 · Received November 26, 1997

    Report

    Report Number
    135045
    Event Type
    Other
    Date Received
    November 26, 1997
    Date of Event
    October 2, 1997
    Report Date
    October 16, 1997
    Manufacturer
    OLYMPUS OF AMERICA
    Product Code
    FDS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMALL PERFORATED AT GE JUNCTION AFTER DUODENOSCOPE PASSED SECONDARY TO SEVERE EROSIVE GASTRITIS, FRAGILITY OF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SCOPE DUODENOSCOPE FDS OLYMPUS OF AMERICA G1F 130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other