It was reported that the a22040a tip broke off and fell into the patient during a bladder evacuation procedure.The broken tip of the device was discovered after the procedure was completed when it was brought for reprocessing.Additional surgical and medical intervention was performed.The patient had to be brought back into surgery for a foreign body removal inside of the patient's bladder.The broken tip was successfully retrieved.According to the report, the patient is currently doing fine.The returned the a22040a lot# 18yw-0405 resection sheath was received for evaluation due to ¿tip came off/break off¿.The user¿s complaint was confirmed.Visual inspection was performed on the received condition and determined that approximately 90% percent of the ceramic beak from the distal end side was broken and missing the broken ceramic beak piece was not returned.There is an approximately 10% portion of the ceramic beak that is still intact on to the sheath from the distal end area.In addition, there are minor dents and scratches noted on the outer sheath of the device.Based on the results of the device evaluation, the cause of the reported complaint is due to mishandling.
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