BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 275983 · Received April 27, 2000

    Report

    Report Number
    8010047-2000-00025
    Event Type
    Malfunction
    Date Received
    April 27, 2000
    Date of Event
    March 27, 2000
    Report Date
    March 29, 2000
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL NURSE TECHNICIAN REPORTED LOSS OF IMAGE WHEN THE GASTROSCOPE WAS TURNED ON PRIOR TO A PT PROCEDURE. IN ADDITION, NURSE NOTICED THAT THE GASTROSCOPE'S DISTAL TIP WAS TOO HOT TO TOUCH. THE SCOPE WAS TURNED OFF AND A SECOND SCOPE WAS USED TO PERFORM THE ESOPHAGASTRO DUODENOSCOPY ("E.G.D.") PROCEDURE. THE CASE WAS COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE KOG THE OLYMPUS OPTICAL CO. LTD GIF-XQ140 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN