(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 for evaluation.No photo available.A device history record review could not be conducted since the lot number was not provided.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.Material from the production line was 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.
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