It was reported that during a cori assisted tka surgery, the real intelligence cori turned off and the blue man appeared on the front of the console screen while registering the femur.They proceeded to do a hard power down from back switch and repowered.The procedure was completed, without delay, using the same device.Patient was not harmed as consequence of this problem.
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The real intelligence cori, part number rob10024, serial number sn (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.Although the product was not returned the software files were downloaded from the device and provided for investigation.The shutdown of the cori system during the femur point collection state was not confirmed.The most likely cause of this system shutdown is a known software issue.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.The risk level is still adequate.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.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 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.
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