Note: this report pertains to the first of two ultratome xl devices used during the same procedure.It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct (cbd) during an endoscopic sphincterotomy (est) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the direction of the cutting wire was incorrect.A second ultratome xl was used; however, during the procedure, the direction of the cutting wire was still incorrect.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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