Qn # (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.The device history record of batch number 74l1402115 that belong to catalog number 780-15 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.The dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported, it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there was no inventory of the involved product code available at the facility and it was not being mfg at the time.If device sample becomes available at a later date, this complaint will be re-opened.
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