(b)(4).The dhr for the late returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet, inc.Kenosha wi facility as part of a (b)(4) pc.Lot in may of 2021.Evaluation of the returned instrument shows that there is no damaged to the outer tube assembly or jaw pivot pin area and the jaws are not lose or misaligned in the open or closed positions.Functional testing shows that this instrument can pick-up, retain, close , and release multiple clips both with and without the use of silastic test tubing.We are unable to validate this complaint since we were unable to find any nonconforming features on the returned device.All 50 instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in response to this complaint and this record will be deemed closed.
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