Condition upon receipt: 1 un-sealed sample, part number 311910115e, from lot number 0209566204 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings).Evaluation: when compared to the assembly drawing: when viewed under magnification, there was some minor wear to the fine diamond grit however this is unlikely to have been noticeable due to the head diameter and extent of wear; just proximal to the head, the shaft was gouged and when mixed with other fluids may have appeared as a dark colored liquid emitting from the end of the outer tube.The gouging of the shaft corresponds to the distal end of the outer tube and supports the tip during use.The information indicates the damage occurred during use.The instructions for use warns that excess pressure applied to the bur may cause damage [excess: exceeded sufficient pressure required for operation].Based on the wear to the bur head and shaft, excess pressure was applied to the bur during use.Actual device evaluated.(b)(4).
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