Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Approximated based on the date the manufacturer became aware of the event.(b)(4) captures the reportable investigation results of wire broken.The returned microknife xl was analyzed, and a visual evaluation noted that the wire in the handle was broken and the hypotube transition was kinked.These findings were consistent with the findings when the device was observed under magnification.An x-ray inspection was performed, and the wire was kinked inside the handle.No other problems with the device were noted.The product analysis revealed that the wire in the handle was broken.It was also found that the wire inside the handle was kinked which could have induced the wire to break inside the handle.These conditions could have been generated due to the technique used during the removal of the device from the pouch or during the preparation.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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