Updated: d8, d9, e4, h3, h4, h6, h10.This report is being submitted to provide additional information based on the device evaluation results.The olympus service center found that the reported ¿the front panel is not functioning and cannot be operated¿ issue was confirmed, and was due to corrosion of the flat cable.Two additional reportable malfunctions were also identified during the evaluation 1.After changing the flat cable, the display was found to not be fully visible and needs to be replaced.2.A tube was found damaged and needs to be replaced.In addition, the evaluation found the following non-reportable device defects: corrosion on foot switch connector, minor corrosion on the rear panel and corrosion on the main board.The non-reported device defects identified in the device evaluation have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.The investigation is ongoing, therefore, the root cause of the reported issues cannot be determined at this time, however, if additional information becomes available this report will be supplemented accordingly.
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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 2 years since the subject device was manufactured.Based on the results of the investigation, the cause as to why the flat cable was corroded could not be identified, and the cause of the faulty front panel unit could not be identified.In regards to the damaged tube, the root cause of the phenomenon could not be identified.Olympus will continue to monitor field performance for this device.
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