Additional information is provided.The company service representative examined the system and was not able to replicate the reported event.Additional information from the customer confirmed that the reported event was due to user error, with the surgeon being unaware that the settings could be adjusted.The system was then tested and met all product specifications.The system was manufactured on january 25, 2008.Based on qa assessment, the product met specifications at the time of release.The 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.The root cause of the reported event can be attributed to user error.The manufacturer internal reference number is: (b)(4).
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