The user facility reported that during an endobronchial ultrasound bronchoscopy (ebus) procedure, the needle had broken off and could not located.There was no report of patient injury.A single-use aspiration needle was used during a bronchoscopy to obtain specimens from lymph nodes in the lungs.The device functioned normally for the first few passes.When doctor got to station 5r, and tried to pull the needle back into the sheath, the device wasn't responding, like it was disconnected from the handle.The needle was removed from the scope and the distal tip was noted to be missing.The doctor then used a different needle to finish his procedure.It was not clear if the needle broke inside or outside the body.It was not seen in the room or specimen containers.The doctor looked extensively for the needle in the lungs, but it was not seen.The patient had an uneventful recovery and was discharged to home in stable condition.
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A single use aspiration needle model na-201sx-4021, lot# 93v 12, was returned as used for evaluation of ¿distal tip missing¿.A visual inspection of the device confirmed distal tip missing and leaving jagged edges, and small indentations on the needle tube as signs of stress.The broken piece of needle was not returned and the measurement was about 20 mm in length.There are bends on the insertion portion (a slight bend at the handle boot, one at mid-section, and another close to distal end).However, the handle section was functional as it could extend or retract the distal end without a problem.The stylet wire was present, but it would not slide easily and a restriction could be felt when trying to push it through due to those bends on the insertion portion.Based on evaluation findings, the reported complaint was confirmed.The needle broke off could be the result of excessive force.Per ifu, do not insert this instrument when the endoscope is angulated.This could damage the endoscope and/or this instrument.If you feel excessive resistance while operating the needle, do not push the needle slider forcibly.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the instrument and/or endoscope.Do not apply bending force to the handle section.Doing so may damage the instrument and/or endoscope.
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