It was reported that, during femur cut stage in a navio assisted surgery, the error "camera infrared lamp is not working properly.This may result in a limited field of view" popped on the screen.The led on the ndi camera polaris spectra was amber.The procedure was completed with the same device without delay.The patient was not harmed.
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H3, h6: the ndi camera polaris spectra, part number pfsr200027, serial (b)(6) and used for treatment, was not returned for evaluation.A relationship between the reported event and the device could not be established.A visual/functional inspection cannot be completed as no device was returned for evaluation.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.While the reported problem was not confirmed during evaluation, the most probable contributing factor(s) to the reported problem is electrical failure within camera.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
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