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 papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the ultratome was advanced through the scope to perform sphincterotomy.During the first attempt of electrocautery, the cutting wire broke.A second ultratome xl was used; however, the cutting wire broke after bowing the tome, prior to electrocautery.Reportedly, there was no part of the device detached inside the patient.The procedure was completed with a third ultratome xl, using the same generator and active cord.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be okay.
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