BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1082141 · Received July 25, 2008

    Report

    Report Number
    8010047-2008-00130
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SOURCE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DID NOT CONFIRM THE USER FACILITY'S REPORT OF IMAGE LOSS. THE UNIT WAS SUBJECT TO EXTENDED TESTING, AND FOUND TO OPERATE APPROPRIATELY, HOWEVER, A PLASTIC RING AROUND THE LIGHT GUIDE CONNECTOR WAS FOUND MISALIGNED, AND THERE WAS A DEEP DENT ON THE RIGHT REAR TOP COVER. ADDITIONALLY, THERE WAS EVIDENCE OF PHYSICAL IMPACT TO THE LEFT SIDE OF THE DEVICE. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. THIS REPORT IS BEING FILED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A UNSPECIFIED THERAPEUTIC VASCULAR PROCEDURE, THE IMAGE WAS COMPLETELY LOST. THE ENDOSCOPE WAS ALLOWED TO REMAIN INSIDE THE PATIENT WHILE THE USERS UTILIZED A SIMILAR, BUT DIFFERENT LIGHT SOURCE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES XENON LIGHT SOURCE GCT OLYMPUS MEDICAL SYSTEMS CORPORATION CLV-S30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK