It was reported that, during set up for a navio assisted surgery, the error "camera infrared failure " popped on the screen.The amber led on the ndi camera polaris spectra was active.The procedure was completed with the same device without delay.The patient was not harmed.
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Section d3 updated.Section h10: the navio polaris camera, pfsr200027, (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The camera was connected to a navio system and a case created.The camera infrared failure error displayed.The event log was evaluated.The reported problem was confirmed.The event log shows numerous infrared failures.A review of manufacturing 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 failure of the internal infrared led board(s) of the camera.The camera is an oem product and cannot be disassembled further to arrive at a root cause.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Internal complaint reference number: (b)(4).
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