It was reported to boston scientific corporation that an ultratome xl was used in the duodenum during a stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, with the scope elevator in neutral position, it was noticed that the cutwire was oriented in the wrong direction.Reportedly, there was no tortuous anatomy or other procedural factors impacting cope positioning and no visible damage to the device prior to putting it through the scope or after the issue occurred.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the end of the procedure was reported to be stable.
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