It was reported that, during a cori-assisted tka procedure, surgeon was mapping the femur when the real intelligence cori screens went black.They waited for them to reboot.They did not and that is when he noticed the blue man on the console screen.They rebooted the cori, restarted the case, calibrated and continued without issue after a non-significant delay.Patient was not harmed.
|
The real intelligence cori, part number rob10024, serial number (b)(6), used for treatment was not returned for evaluation, therefore a device analysis was unable to be performed.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still within the product risk profile.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with console software bug.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
|