(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.No photo available for evaluation.A device history record review could not be conducted since the lot number was not provided.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 device sample involved in this customer complaint.However material from the production line was functionally inspected and no issues were detected that can lead this customer complaint.If the device sample becomes available at a later date this complaint will be re-opened.
|