The customer reported that her evis lucera elite xenon light source caused the monitor to turn completely black during a colon procedure.According to the initial reporter, this took place about half way through the procedure while the staff were navigating the transverse colon, the screen went back, causing the spare lamp to come on.Reportedly, after restarting the device, the colonoscopy was completed without any patient harm, using the subject device with poor quality lighting.According to the initial reporter, this event occurred 3 times.This report captures event 3 of 3.The other reports are captured under patient identifiers: (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.The following sections were corrected: g3, the aware date should be 31-mar-2022.It has been nearly 8 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a root cause could not be identified, the phenomenon was not duplicated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The cause of the reported event cannot be conclusively determined.Olympus will continue to monitor field performance for this device.
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