It was reported that, during a navio assisted tka surgery, a navio surgical system korea showed an internal error after the femoral cutting.Tried many times with previous save case but failed to continue, same error occurred.Surgery was finished after a non-significant delay and switching to a manual procedure.The patient was not harmed beyond the reported problem.
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H3, h6: the navio surgical system korea, part number rob00079, serial number (b)(6), 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 navio surgical technique guide for knee arthroplasty (500197 rev c) provides guidelines for recovering to a fully manual procedure in the ¿recovery procedure guidelines¿.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 console 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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