(b)(4).Visual inspection of the returned autotome rx device found the tip damaged and the working length kinked and twisted in the distal section.No other visual damage was noted.A functional evaluation was performed by introducing the device through a duodenoscope.After introduction, the device was not correctly oriented due to the twisted working length and the kink, and the tip could not be rotated to adjust orientation by the handle movement due to the kink.The reported event was confirmed.The damage to the device (working length twisted, kinked, tip damaged) caused incorrect orientation of the device.Based on the condition of the device, the damage observed could be generated by manipulation of the device during the procedure during insertion of the device inside the scope.Therefore, the most probable cause of this complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
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It was reported that an autotome rx 44 device was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the physician found the cutting wire orientation was wrong and the tome was bowing out of plane.The procedure was completed with another autotome rx 44 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 stable.
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