It was reported that upon starting the distal bur of the femur with the real intelligence robotic drill in a cori-assisted tka surgery, a drill disconnect error was displayed (case-(b)(4)).The troubleshooting steps were followed and the burring continued.Later, upon entering the tibia cut screen a generation model error appeared (case-(b)(4)).They removed a few points, but the error did not clear.This was done a few more times.Then, more points were collected, but the error still appeared.More points were collected and on the 5th or 6th try, it was possible to get past this error.The procedure was completed without significant delays (fewer than 30 minutes).The patient was not harmed.
|
H3, h6.The real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, visual and functional inspections could not be performed.Screenshots of the case were provided and confirmed the warning messages upon entering the tibia bone removal stage: ¿bone model generation error¿.This is a known software issue that has been corrected and released in cori-v1.4.3 software.Refer to the real intelligence cori for knee arthroplasty user manual for data point collection, including tibia free collection.If a collection error occurs, a message displays, reporting the specific error to the user, and providing instruction for solution.Most indications require clearing the message from the screen, by pressing ok, and performing the steps again to re-collect.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.Escalation actions applicable to the scope of the reported complaint have been identified, and it was determined that no further action is required at this time.This issue will be continuously monitored through complaint investigation and post market surveillance.
|