It was reported that, before a navio ukr procedure, the screen would not boot up.They received two different errors on the screen (errcode = 2000000000000 and errcode = 1).They shut down navio as instructed on screen, powered up with navio unplugged then plugged back in when smith and nephew slash came on screen.After the reboot, they proceeded without delay.No other complications were reported.
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G3, h2, h3, and h6: the product, navio surgical system us, npfs02000, (b)(6) used for treatment was not returned for evaluation, however photos were provided for evaluation.A relationship between the reported event and the device was confirmed.Photo 1 shows error code 2000000000000 and photo 2 shows error code 1.A functional evaluation could not be performed because the product was not returned.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.The most likely cause of this event is a ups issue.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.H6: update codes.
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