(b)(4).The device history review of the product visistat 35w non-sterile lot #73k2000440 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.During visual inspection was observed; staples were received in correct position.Trigger was observed pre-activated.Functional inspection performed as follows.Device was activated (fired) the staplers were properly formed and released, none defects were observed during develop of this testing.A verification of failure mode reported in the current manufacturing process was conducted as follows: 13 staplers were taken from the current production from p/n 528236 visistat 35w non-sterile lot# 73j2100436 the staplers were functionally inspected (fired) and issue reported "misfire/jam-staples not forming/closing" was not observed in the current manufacturing process, the staples were loaded and released correctly.Revision of fmea-08-028 rev 05 was performed and the failure mode is already including it, no update is required.A corrective action is not required at this time as the reported complaint could not be confirmed for the sample that was returned.One (1) stapler from catalog number 528236 visistat 35w was received, used, without original package, only complaint documentation.During visual inspection was observed.Staples were received in correct position.Trigger was observed pre-activated, during functional testing the stapler was formed and released properly the staplers.A total of 10 staplers were fired and no defects were detected during this testing; therefore, at this time is not possible confirmed the defect reported "jamming".
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