H3, h6: the ndi polaris camera, used in treatment, was returned for evaluation.There was a relationship between the device and the reported event.The medical investigation found that no patient injury resulted from the conventional procedure or the minor surgical delay.No further medical assessment is warranted at this time.Should clinically relevant documentation or information become available, the clinical/medical task may be re-evaluated.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review concluded this was a repeat issue.The navio user's provides instruction for camera setup, operation and troubleshooting.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device revealed no discrepancies that may have contributed to the reported problem.A functional evaluation was performed and the camera event log was evaluated.The event log indicates multiple illuminator faults between (b)(6) 2019 to (b)(6) 2020.The camera was unable to connect to the calibration module.The unit was then connected to a known good navio system, which revealed that upon reaching the handpiece calibration stage, the error message present in the original complaint appeared.The complaint was confirmed.A factor that may have contributed to the reported complaint include: 1) the illuminator leds on the camera can go bad over time with use and cause floating "dead zones" in the camera view - this problem is physical in nature in the camera only and it needs to be serviced.No containment or corrective actions are recommended at this time.
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