A company representative, on behalf of a user facility, reported that during a diagnostic endobronchial ultrasound procedure using the evis eus ultrasound bronchofibervideoscope with a single use aspiration needle, there was resistance.It was initially stated there was a hole on the insertion channel.Additional information was obtained to clarify the event.Upon the first pass with the first needle, the physician met resistance, so the pass was stopped.The needle was taken out of the scope, and it was noticed that the end of the catheter was broken off and the metal tip was sticking out.The needle was placed aside.A second needle was used, and another pass was tried.Resistance was felt again, so the needle was pulled out.The scope was removed, and the physician tried to put the catheter down the scope outside of the patient and could not advance the needle to the end of the scope.A second scope was used with another (third) needle to finish the procedure, and it was not cancelled.Due to the product issues, the procedure was prolonged by about 30-40 minutes.It was reported that the scope was plugged into the tower, and there were no error messages associated with this event.The patient's condition was not affected by this, and no interventions were required.Patient identifier (b)(6) is for the evis eus ultrasound bronchofibervideoscope.Patient identifier (b)(6) is for the single use aspiration needle.Patient identifier (b)(6) is for the single use aspiration needle.
|