(b)(4).The dhr for the instruments in question was reviewed and found completely without any irregularities.This instrument was manufactured at the tecomet, kenosha facility as part of a 50pc.Lot in (b)(6) 2015.The returned instrument was evaluated and found that the jaws are in line with each other in the open and closed position and there are no visible signs to the jaws.Further evaluation showed that this instrument picks up, retains, closes and releases multiple clips as required of its function both with and without the use of silastic test tubing.Parts were 100% visually inspected and tested at the tecomet, kenosha 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.We are unable to validate the alleged complaint since we were unable to replicate the alleged issue.At this time it is un-determined what caused the alleged issue at the customers site.No corrective action required at this time.Per fda guidelines for manufacturers which state: "manufacturers are other remarks: required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.
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