BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 2211218 · Received July 12, 2011

    Report

    Report Number
    8010047-2011-00150
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP ON THIS REPORT TO GATHER ADD'L INFO REGARDING THE REPORTED EVENT, HOWEVER, NO DETAILED INFO REGARDING THE OCCURRENCE WAS PROVIDED. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE EVAL CONFIRMED AND IMAGE LOSS. THE SOURCE OF THE IMAGE DIFFICULTY WAS ISOLATED TO A DAMAGED RGB MONITOR CABLE CONNECTION, WHICH INTERFERED WITH THE PROPER SEATING OF THE RGB MONITOR CABLE. ONE OF THE RGB MONITOR CABLE CONNECTOR SCREW WAS BROKEN AND A PORTION REMAINED LODGED IN THE REAR OF THE VIDEO PROCESSOR. THE CAUSE OF THE BROKEN CONNECTOR WAS DETERMINED TO BE DUE TO PHYSICAL DAMAGE. THE DEVICE WAS SERVICED AND WAS RETURNED TO THE USER FACILITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS IS THE FIRST OF TWO REPORTS. CROSS REFERENCED MFR REPORT # 8010047-2011-00151.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN UNSPECIFIED TYPE OF ENDOSCOPY PROCEDURE, THEY EXPERIENCED AN IMAGE LOSS. THERE WAS NO REPORT OF ANY PT HARM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BUT SIMILAR LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II VIDEO SYSTEM CENTER VIDEO PROCESSOR FDF OLYMPUS MEDICAL SYSTEMS CORPORATION CV-180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1