It was reported that during a cori assisted ukr when they went to cut femur, the real intelligence 24 in.Touch screen went black.It had power but flashed box that said "no signal".They proceeded to unplug the display port and when plugged back in, the screen came back on.Then when they went to cut femur, the tablet and touchscreen went black as the blueman appeared on the console.They performed hard reboot and logged back into case and resumed.Plan had saved and they executed the case with cori and were able to finish.The procedure was completed, with a non-significant delay, using the same device.Patient was not harmed beyond the problem reported.
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H3, h6: the cori touchscreen pn rob10003, sn (b)(6), used in treatment, was not returned for evaluation.A visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.A review of manufacturing records indicates the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.No reasonable contributing factors could be identified based on the received complaint information and investigation results.The product was not returned and no evidence was made available to link the complaint to an escalation event.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Smith & nephew has not received adequate materials to fully evaluate the complaint, but if additional relevant materials are later received the complaint can be reopened.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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