BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA VIDEO SYSTEM CENTER

    MDR report key: 2000015 · Received February 17, 2011

    Report

    Report Number
    8010047-2011-00029
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 19, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS CONTACTED THE USER FACILITY VIA PHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT WITH NO RESULT. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A REVIEW OF THE INSTRUMENT HISTORY SHOWED THAT THE USER FACILITY ORIGINALLY PURCHASED THE DEVICE ON (B)(6) 2001, AND THE DEVICE WAS LAST SERVICED BY OLYMPUS ON (B)(6) 2007. THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, AN OLYMPUS TECHNICAL REPRESENTATIVE ADVISED THE USERS TO RETURN THE DEVICE TO OLYMPUS FOR EVALUATION, BUT AS TO THIS DATE THE DEVICE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF SIGNIFICANT AND RELEVANT INFORMATION BECOME AVAILABLE AT A LATER TIME, THEN THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS AN MDR IN A ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "TYPED CORRECT PATIENT DATA ONTO KEYBOARD BUT DID NOT DISPLAY ON PHOTOS WHAT WAS TYPED, IE. DATE, AGE, ETC. THERE WAS NO PATIENT HARM REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA VIDEO SYSTEM CENTER VIDEO PROCESSOR FDF OLYMPUS MEDICAL SYSTEMS CORP CV-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR