(b)(4).Post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, an engineering review, a pmv review of complaint trends, and an evaluation of the returned device.The instrument was evaluated for electrical conductivity; proper conductivity was observed.The rotation knob functioned properly.The jaws were applied to test media and could grasp the media without issue.The handles opened and closed without any hang ups noted.No functional abnormalities were observed.Engineering determined that the slight misalignment of the jaws, which doesn't violate the device specifications, does not hinder the ability of the device to grasp, manipulate or cauterize tissue.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened.
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