It was reported that, during set up for a navio assisted tka surgery, a navio surgical system korea showed a pfs control hardware failure error during initialization (errcode=40000000000).Surgery was performed after a non-significant surgical delay and changing to a manual procedure.No harm to the patient or further complications reported.
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Section h3, h6: the navio surgical system korea, part number rob00079, serial number (b)(6) intended 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 and the documented risk level is still within the product risk profile.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with corrupt cpu bios settings.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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