BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1012695 · Received March 15, 2008

    Report

    Report Number
    8010047-2008-00044
    Event Type
    Malfunction
    Date Received
    March 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE OLYMPUS LIGHT SOURCE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE LIGHT SOURCE WAS TESTED WITH A TEST POWER CORD ON HIGH INTENSITY AND AUTO AND MAXIMUM BRIGHTNESS FOR SEVERAL DAYS, AND THERE WERE NO ILLUMINATION, IMAGE, OR OVERHEATING DIFFICULTIES NOTED. THE DEVICE PASSED ALL FUNCTIONAL TESTS WITHIN THE SPECIFICATIONS. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY CLAIMED THAT DURING MULTIPLE THERAPEUTIC LAPAROSCOPY PROCEDURES, LIGHT SOURCE BECAME TOO HOT, WHICH CAUSED THE IMAGE TO BECOME VERY DARK OR COMPLETELY LOST, AND HAD DAMAGED THEIR SURGICAL TELESCOPES. THE PROCEDURES WERE REPORTEDLY COMPLETED WITH A NON-OLYMPUS HEAD LAMP. THERE WERE NO PT INJURIES REPORTED. THE USER FACILITY REPORTED TO HAVE OBSERVED SIMILAR PHENOMENA IN PREVIOUS PROCEDURES, BUT ELECTED TO REUSE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-S40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK