This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over ten (10) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that irregular color tone was occurred due to the damage of image sensor unit(disconnection, etc.) or breakage of the mounting components (integrated chip, capacitor, etc.) of the electric board due to use stress, external factors, or handling.The event can be inspected by following the instructions for use which state: operation manual, chapter 3 ¿preparation and inspection¿ section 3.8 ¿inspection of the endoscopic system¿.Olympus will continue to monitor field performance for this device.
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