It was reported that, during cori assisted tka surgery, the real intelligence robotic drill had a connection issue and gave an internal error on the cori.Procedure was resumed, after a non-significant delay, with a back-up device.No patient complications were reported.
|
H3, h6: the real intelligence cori, part number rob10024, serial number sn000419, used 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 failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with internal exposure motor connectivity issues.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.
|