Device evaluation: upon completion of the investigation it was noted that the manufacturing documentation was reviewed for any variations in current process and no variations were found.A light brown 'spot' (under 0125" in diameter) was on the top pattie in the pack, directly around/below the area of the green string.The spot was produced when the string was welded to the cottonoid material.The cottonoid is formed from a rayon material.During processing this rayon material is broken down into small, loose fibers.If the fibers do not break down enough, a small cluster of fibers can result.This in turn creates a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.We use an automated machine to produce this product code.The patties are inspected by a computer vision inspection system that inspects the patties for defects.The burn marks are difficult to detect due to the type of color filters used on the camera lens.This sample under question was tested under the cameras on our automated pattie machine and the marking was not able to be detected by the camera system.The marking was found to be too faint to be detected my the system.Since the marking is from burnt rayon material, it would not affect the patient during surgery.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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