BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 925776 · Received April 2, 2007

    Report

    Report Number
    8010047-2007-00042
    Event Type
    Malfunction
    Date Received
    April 2, 2007
    Date of Event
    March 2, 2007
    Report Date
    March 2, 2007
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION DID NOT CONFIRM THE USER'S CLAIM OF IMAGE PROBLEMS. THE DEVICE WAS TESTED AND WAS ACTIVATED FOR FIVE HOURS AND THE DEVICE PASSED ALL FUNCTIONAL TESTS WITHIN SPECIFICATIONS. DESPITE THE FACT THAT THE DEVICE MEETS ALL SPECIFICATIONS, OLYMPUS HAS DEVELOPED A SOFTWARE UPGRADE FOR THE CV-180 VIDEO PROCESSOR THAT WILL REDUCE THE LIKELIHOOD OF AN INTERMITTENT CONNECTION RESULTING IN THE APPEARANCE OF A COLOR BAR PATTERN. THE CV-180 VIDEO PROCESSOR, CLEARED IN K051645, IS THE VIDEO SIGNAL PROCESSING TECHNOLOGY THAT ENABLES THE ENDOSCOPE TO ILUMINATE, ENHANCE, VIEW, RECORD AND TRANSMIT VIDEO DATA OF ENDOSCOPE IMAGES. OLYMPUS IS UPGRADING ACCOUNTS, REPRESENTING DEVICES, INCLUDING THE SUBJECT FACILITY, DUE TO APPEARANCE OF A COLOR BAR DISPLAY ON THE MONITOR. THESE DEVICES WERE DISTRIBUTED IN 2006 AND 2007. ATTACHED PLEASE FIND A COPY OF THE CUSTOMER COMMUNICATION AS WELL AS THE LIST OF ALL CONSIGNEES. NO INJURIES OR ILLNESSES HAVE OCCURRED WITH THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ERCP, THE VIDEO IMAGE WAS LOST AND REPLACED BY A COLOR BAR DISPLAY ON THE MONITOR. THE USERS WERE ABLE TO RECOVER THE VIDEO IMAGE BY MOVING THE ENDOSCOPE VIDEO CABLE. HOWEVER, THE USERS STATED THAT THE IMAGE WAS LATER LOST AGAIN, AND THEY WERE NOT ABLE TO RECOVER THE IMAGE BY MOVING THE VIDEO CABLE. THE PROCEDURE WAS COMPLETED WITH A TRAVEL CART. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO PROCESSOR LLZ OLYMPUS OPTICAL CO., LTD. CV-180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR