The customer reported that the system was producing an occlusion sound.The surgery was completed with a backup system with no harm to the patient.The company service representative examined the system and was not able to replicate the reported event.The system was then tested and met all product specifications.The system was manufactured on february 18, 2014.Based on qa assessment, the product met specifications at the time of release.The phaco handpiece serial number (s/n) was not provided and could not be determined based on the information provided.Therefore, manufacturing information could not be obtained.With no additional, related information provided, the customer reported event could not be confirmed.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).
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