The company representative (did not) confirm nor replicate the reported event.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.The dhr was completed and reviewed by qa to ensure that the product was manufactured in compliance with the device master record.Based on qa assessment, the product met specifications.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The system was found to have no problem.Therefore, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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