It was reported that, before a cori-assisted surgery, "front panel error" message popped on the screen.There was no display on the console screen.Even though the machine was restarted a couple of times, the error was persistent.Due to this, surgery was performed by manual procedure instead.No injuries reported.
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Section h3, h6: the real intelligence cori, part number rob10024, serial number (b)(6)., intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.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 real intelligence cori for knee arthroplasty user manual (500230 rev d) provides guidelines for recovering to a fully manual procedure in the "recovery procedure guidelines, appendix d" 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.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with a console front panel error.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.D11: concomitant medical products and therapy dates.
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