It was reported to boston scientific corporation that a ultratome xl device was used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cut wire of the device broke.Nothing detached and fell in the patient.The procedure was completed with another ultratome xl device.There were no patient complications 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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