(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device, or a picture of the alleged defect was not provided at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this c omplaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.
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