The complainant reported two suspect device lot numbers 26417553 or 27181793; however, the correct suspect device lot number has not yet been confirmed; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that an ultratome xl was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when they pulled the handle to bow the tip, there was a resistance felt and the pull wire that threads up from the handle going to the tip appeared to be broken.Cautery had already been performed before the problem happened.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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