BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1061067 · Received June 13, 2008

    Report

    Report Number
    8010047-2008-00102
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 16, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SOURCE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE PRESENCE OF BURNT FOREIGN PARTICLES OF WHICH APPEARED TO BE PLASTIC INSIDE THE ENDOSCOPE CONNECTOR SOCKET. THERE WAS ALSO EVIDENCE OF PARTICULATE MATTER ON THE OPTICAL LENS, WHICH MOST LIKELY CAUSED THE USER'S EXPERIENCE WHEN THE LIGHT SOURCE WAS ACTIVATED. THE PARTICULATE MATTER WAS REMOVED FROM THE SOCKET, AND THE DEVICE OPERATED FOR SEVERAL HOURS WITHOUT DIFFICULTY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AS THEY WERE PREPARING TO START A CYSTO-FULGURATION PROCEDURE, THE STAFF NOTED THAT THE LIGHT CORD OF AN ENDOSCOPE WAS SMOKING AND APPEARED TO BE VERY HOT. THE PROCEDURE WAS REPORTEDLY CANCELLED AND THE PT RESCHEDULED THE PROCEDURE AT ANOTHER TIME. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLH-250

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK