The reported oad was received at csi for analysis.Visual examination of the oad did not reveal any damage.When tested for functionality, the oad spun on all speeds and all expected leds were visibly illuminated.At the conclusion of the device analysis, the report that a vessel perforation occurred could not be confirmed through analysis.The oad functioned as intended when tested.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.An event involving the guide wire used in this procedure was submitted under mdr-3004742232-2020-00337.Csi id: (b)(4).
|