The lot complaint history was reviewed.This is the third complaint for the finished goods lot and for this issue for this lot.The device history record shows the product was released per specifications.No sample was received.Therefore, no visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and no root cause could be established.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.If a sample is returned at a later date, the investigation will be reopened and the sample investigated.(b)(4).
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