It was reported to boston scientific corporation that a microknife rx 3l needle knife was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, there were no issues with needle movement (extension/retraction) when the device was tested before being put through the duodenoscope.However.During the procedure, inside the patient, when the handle was actuated to extend the needle, the needle did not come out in a controlled manner.The needle came out suddenly, and had to be partially retracted afterwards.The procedure was completed with the same device, and there were no patient complications reported as a result of this event.
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