BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 502250 · Received December 18, 2003

    Report

    Report Number
    8010047-2003-10110
    Event Type
    Injury
    Date Received
    December 18, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 21, 2003
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE INSERTION TUBE OF THE ENDOSCOPE WAS "STIFF." THE PROCEDURE WAS NOT COMPLETED. THE PT WAS ADMITTED TO THE EMERGENCY ROOM FOR AN OPERATION TO REPAIR A PERFORATION SUSTAINED DURING THE INITIAL PROCEDURE. THERE ARE NO FURTHER COMPLICATIONS TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE GCQ OLYMPUS OPTICAL CO. LTD. CF-20L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R