It was reported that during a navio procedure, the camera start to show orange led, and warning message appeared on the screen, telling that camera has no full functionality and reduced field of view (infrared).The surgery was completed by using the same device with a minimum delay (less than 30 minutes).This is the second of four incidents.No other complications were reported.
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H3, h6: the reported device (pn 200027 sn (b)(6) ) used for treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.The reported error message indicates that the illuminator leds have gone bad.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Additional information: d4 g1 mdr reporting contact name and address and phone number.
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