The reported device (pn 200027 (b)(6), used in treatment, was returned for evaluation.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reports, this issue will continue to be monitored.This failure mode is identified in the navio risk profile.The navio user's manual (500196) provides instruction for camera setup, operation and troubleshooting.A relationship, if any, between the subject device and the reported event could not be determined.Nothing was identified visually that contributed to the reported problem.Functional evaluation confirmed the reported event, the illuminator camera error led was present when camera was plugged in.The camera was connected and a case was attempted.The camera throws a ""camera infrared lamp is not working correctly"" fault error.The illuminator leds on the camera can go bad over time 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.Per complaint details, the device malfunctioned/¿infrared signal weak warning came up prior to bone removal¿.Per the field report, the navio case was aborted and the case was performed via manual instrumentation without report of patient injury, surgical delay, or any further complications.Responses to the requested documentation/clinical information were not provided as of the date of this assessment.Based on the information provided the impact beyond the aborted navio case and modified surgical technique with manual instrumentation could not be definitively determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.
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