It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, it was noticed that the spyscope ds working channel sleeve protruded from the distal end of scope.Reportedly, no part of the device detached.The procedure was completed with this 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 fine.
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