Fe minor scratches on the device.This device deemed non-repairable and will be placed into long term hold."faulty parts" was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation was not required as the reported event was not associated with the manufacturing process and/or the potential cause of the defect could not be associated to manufacturing.At this point in time, no corrective action was required, and no further action was warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint was observed in the field.
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It was reported by the sales rep that during returning inspection, it was observed that the controls on the camera head ac - c-mount device were functioning sporadically and the picture was going to red lines.During in-house engineering evaluation, it was determined that the device had intermittent loss of image and displayed intermittent red lines.There was no procedure nor patient involvement reported.No additional information was provided.
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