(b)(4).Post market vigilance (pmv) and engineering led an evaluation of one instrument 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, a pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device.The visual inspection of each device noted the jaws were misaligned.Each instrument was evaluated for electrical conductivity; proper conductivity was observed both in normal position and in roticulated position.The rotation knob functioned properly, and the jaws opened and closed grasping test media without difficulty.Engineering noted misalignment at the jaws assembly.The jaw alignment was measured and was within specification.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.He event did not meet the regulatory reporting criteria.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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