It was reported that during a gallbladder removal surgery, the high flow insufflation unit sounded a long alarm and all the leds (light-emitting diodes) on the front panel went off.After restarting 3 times, the problem improved, so the procedure was continued and completed.The issue occurred during a therapeutic cholecystectomy procedure.The procedure was completed with the same set of equipment.There were no reports of patient harm.
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: d4, d9, h3, h4, h6, h10.Corrected fields: e1.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that long alarm sounded and all the light-emitting diodes on the front panel went off occurred due to printed circuit board failure.Olympus will continue to monitor field performance for this device.
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