(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, inc.(b)(4) facility as part of a (b)(4) pc.Lot in april of 2015.The returned instrument was evaluated and found that the jaws are aligned with each other and the tip set as received is correct per print specs.Further evaluation showed that this instrument picks up, retains, closes and releases clips both with and without the use of silastic test tubing as required of its function.We are unable to validate the alleged complaint since we are unable to duplicate the alleged issue.Parts were 100% visually inspected and tested at the tecomet, (b)(4) facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product as this is a standardized process for all instruments manufactured at this facility.No corrective action required at this time.
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