It was reported that, during a cori assisted tka surgery, on the gap assessment, and implant planning screens, image glitches were found and the screens became difficult to view.After advancing to forward screens they went away.The procedure was completed with the same device without significant delays.The patient was not harmed.
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H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The case files were provided and reviewed.Screenshots confirmed the block model overlapping the bone models in the implant planning screen and gap assessment screen.The most likely cause of the reported issue is a known software issue associated with the mesh generation.A bug has been identified for this issue and is under further investigated by the software engineering team.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.Based on the investigation, no containment or corrective actions are recommended at this time.
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