(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an ultratome xl was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire broke upon cutting.Reportedly, no part of the cutting wire was detached and fell into the patient.Additionally, it was reported that the device was energized when not in contact with tissue.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Note: a photo of the complaint device outside the patient was provided by the complainant and shows the cutting wire broken.
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