BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 446276 · Received February 27, 2003

    Report

    Report Number
    8010047-2003-00034
    Event Type
    Malfunction
    Date Received
    February 27, 2003
    Report Date
    January 27, 2003
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT THE IMAGE FROZE DURING THE PROCEDURE. THERE WERE NO COMPLICATIONS OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE GCK OLYMPUS OPTICAL CO. LTD. GIF-Q160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN