The company service representative examined the system, but was unable to replicate the reported event.The company service representative checked, and the laser worked properly.The system was then tested.And met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
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