(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not provided.The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the device sample is not available for evaluation.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 the device sample becomes available at a later date this complaint will be updated.
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