BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 316811 · Received February 16, 2001

    Report

    Report Number
    8010047-2001-00009
    Event Type
    Malfunction
    Date Received
    February 16, 2001
    Report Date
    January 17, 2001
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: ON OR ABOUT 1/17/01, A MEDICAL OFFICE REP REPORTED THAT BLACK LINES APPEARED ON A VIDEO MONITOR WHEN A CFQ-140L COLONOSCOPE WAS CONNECTED TO IT DURING A PROCEDURE. THE PROCEDURE WAS DISCONTINUED AND THE SCOPE WAS SENT TO OLYMPUS FOR INSPECTION. NO PROBLEMS WERE DETECTED DURING THE INVESTIGATION AND THE COLONSCOPE WAS RETURNED TO THE OFFICE. ON OR ABOUT 1/29/01, THE OFFICE REP REPORTED THAT FROZEN AND LOST IMAGE WAS EXPERIENCED WITH THE SAME SCOPE DURING ANOTHER PT EXAMINATION. THE REP STATED THAT THE PROCEDURE WAS COMPLETED WITH A SECOND SCOPE. THERE WERE NO COMPLICATIONS ASSOCIATED WITH EITHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6229 OLYMPUS COLONOSCOPE FDF OLYMPUS OPTICAL CO. LTD. CFQ-140L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN