(b)(4).Potential lot numbers reported: 74a1602818, 74a1603215, 74b1602277 and 74c1600209.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo for review.The device history record of batch number (b)(4) that belong to catalog number 1884 has been reviewed and no issues or discrepancies were found which could potentially be related 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.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.However material from the production line was inspected and no issues were detected that can lead this customer complaint.If device sample becomes available at a later date this complaint will be re-opened.
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