(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned at this time.No photo for review.The device history record was reviewed and showed that the product was assembled and inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If device sample becomes available at a later date this complaint will be re-opened.
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