This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the reported event (device shuts down by itself) occurred due to a faulty printed circuit board (cr board).The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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Additional information was received.Which confirmed, the unit failed, during a therapeutic laparoscopic, total hysterectomy.On (b)(6) 2023, the screen went blank and pressure was lost.The staff restarted, the machine and it worked normally without any issue, no harm to the patient.It was sent to biomed for inspection.They couldn¿t find any issue, so it was put back into use.On (b)(6) 2023, the same thing happened, during a therapeutic laparoscopic, total hysterectomy.The device shut down, restarted and they performed the rest of the case without issue.There was no harm to patient.Additional details have been requested, regarding the reported event.At this time, no additional information has been provided.If new information is received, a supplemental report will be submitted.
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