The device is not returned as the issue was resolved by connecting the cables.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communication.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.As reported for this event, the device yielded an image that was tinted blue with a monitor out cable to a third-party monitor.The image issue was resolved when the sdi was used as the input to the monitor after the sdi cable was attached to the device.There was no reported patient involvement.The device had no malfunction, the image issue was as a result of the customer using the rgb cable instead of the sdi cable when connecting to the monitor.The instructions for use includes the following statements: the color tone of the endoscopic image is unusual.Possible cause: the monitor cable is connected incorrectly.Solution: connect the monitor cable properly as described in section 8.5, monitor on page 170.
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