(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 was reviewed and showed that there were no issues related to functional issues neither on the product nor its components during the mfr of the material.No corrective action can be established at this time since the defective sample or a picture is available fore evaluation.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 is no inventory of the involved product code available at the facility nor is it being manufactured at the time.If device sample becomes available at a later date tis complaint will be re-opened.
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