Evaluation summary: post market vigilance (pmv) and engineering led an evaluation of two devices 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 reported condition for this incident was that the jaws were misaligned and damaged.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 reticulated position.The rotation knob functioned properly, and the jaws opened and closed grasping test media without difficulty.Engineering noted some misalignment at the jaws assembly.The jaw alignment was measured and was within specification.Visual and functional testing of the returned product confirmed the product met quality release specifications that were tested regarding the reported condition.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.The file was concluded to be tested satisfactorily as the device was found to meet all visual and functional test specifications.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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