It was reported that, during a navio-assisted surgery, the resection check numbers were way off.The staff claimed the arrays did not move.It is unknown how the issue was solved; however, it caused a delay of less than 30 minutes.The patient outcome is unknown.
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H3, h6: the navio surgical system (us), (b)(6) used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may be associated with user variance/technique (tracker array movement).Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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