(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was manufactured at the (b)(4) as part of a 50 pc.Lot in (b)(6) of 2017.The returned instrument was evaluated as received and found that the handle to jaw mechanism was sluggish/binding and knob rotation mechanisms was dry and sluggish feeling thus we are able to validate this complaint.After the initial evaluation this instrument was properly lubricated, and 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 function tested at the (b)(4) 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.At this time, it is un-determined what caused the alleged issue, but it is suspected that the customer did not "lubricate" the instrument prior to sterilization as recommended in ifu (l06109 r04) supplied with the instrument which states "the instrument must be cleaned, lubricated, functionally checked, and sterilized prior to each use.Use a non-silicone, waterbased lubricant prior to sterilization.".
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