It was reported that, during machine setup before a navio procedure, it was found that the camera was not getting connected.The two green leds on the polaris camera were solid as normal.Also, the usb cables were reconnected from cpu; the camera cable was also reconnected.However, the camera could not establish connection.On the hardware connect screen, it was shown that the camera was not getting connected.There was no patient involvement.No other complications were reported.
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Confirmation received that the camera was not faulty.Internal complaint reference: case-(b)(4).Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the device did not cause or contribute to a death or serious injury, nor has it been implicated by a physician as having caused such injury.It was confirmed that the camera did not malfunction, and that there was no deterioration in the characteristics or performance of the device.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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