It was reported by the user facility that a patient underwent a retrograde intra renal surgery (rirs) procedure.While attempting to retrieve the stone, the forcep would not work.The device was replaced and the attending physician indicated that the flexible ureteroscope was placed in the left percutaneous nephrostolithotomy (pcn) using an ngage nitinol stone extractor.The procedure was successful and there were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.No further information was provided.
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A review of the following: functional test, review of complaint history, review of device history record, review of manufacturing instructions, review of quality control, and visual inspection.A functional test was performed and the udh handle did not actuate the basket format.A visual examination of the device noted the basket sheath is kinked approximately 1 cm from the distal tip and again at 37 cm from the distal tip.The handle was disassembled and the basket formation could not be manually actuated.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the investigation evaluation the root cause is unknown.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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