BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 297937 · Received September 25, 2000

    Report

    Report Number
    8010047-2000-00062
    Event Type
    Malfunction
    Date Received
    September 25, 2000
    Report Date
    August 31, 2000
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL NURSE REPORTED THAT AN IMAGE WENT BLANK BUT WAS RETRIEVED DURING A COLONSCOPY PROCEDURE. ACCORDING TO THE NURSE, WHEN THE IMAGE WAS RETRIEVED, IT WORKED INTERMITTENTLY WHILE THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. SHE MENTIONED THAT THE SCOPE WAS NOT REPLACED DURING THE EXAM SINCE THE IMAGE PROBLEM OCCURRED TOWARD THE END OF THE CASE. THE IMAGE WENT BLANK WHEN THE SCOPE WAS USED FOR A SECOND COLONSCOPY PROCEDURE. ONCE AGAIN, THE IMAGE WAS RESTORED INTERMITTENTLY BUT DURING THIS PROCEDURE, THE IMAGE EXHIBITED RAINBOW COLORS AND THEREBY PREVENTED THE PHYSICIAN FROM COMPLETING THE PROCEDURE WITH THAT SCOPE. THE COLONSCOPE WAS REMOVED FROM THE PT AND REPLACED WITH A SECOND COLONSCOPE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS RELATED TO THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO COLONOSCOPE KOG THE OLYMPUS OPTICAL CO. LTD. CF-100TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN