It was reported that during a navio tka procedure, the camera would not connect.The amber light was displayed on camera, and they attempted multiple times to unplug and re-plug the camera cord without success.They unplugged both ends and re-booted, but the amber light remained unchanged.They reverted to manual instrumentation.No other complications were reported.
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The reported device, 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 be determined.Nothing was identified visually that contributed to the reported problem.The aak assessment was not able to be performed.The camera would not connect to the navio system and the camera error led was present when camera was plugged in.The camera event log was evaluated, and the event log shows the camera firmware is missing or corrupt.The malfunction was due to component failure, however the camera is an oem part and cannot be further disassembled to arrive at a root cause.No containment or corrective actions are recommended at this time.The medical investigation found that per complaint details, the device malfunctioned during use and the navio procedure was reverted to manual instrumentation.It was communicated that the operative report/imaging was not available; however, per correspondence, there was no surgical delay or patient injury/harm due to the reported events and the surgeon was satisfied with the surgical outcome.Product evaluation (functional) confirmed the complaint.Based on the information provided the modified procedure did not result in patient injury/impact and the patient¿s current health status is good; therefore, no further medical assessment is warranted at this time.Our reference number: (b)(4).
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