The user facility reported during a percutaneous nephrolithotomy procedure, the physician confirmed the ncircle tipless stone extractor basket could open before the patient contact.The device would later not open or close after it was inserted into the patient's body.Another device was used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence additional information has been requested from the customer.
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A review of complaint history, device history record, manufacturing instructions, specifications and quality control data was conducted during the investigation.A review of the device history records found 0 nonconformance issues.A review of complaint history records revealed this is the only complaint associated with lot # 8208647.One device was returned for investigation.The device was returned with the handle in the closed position and the basket formation was in the closed position.The collet knob is tight and secure.The mlla (male luer lock adaptor) is loose.The pett measures 2.5 cm in length.A visual examination noted the support sheath is bowed in appearance.A functional test determined the handle actuated the basket formation, but does not fully open.The handle was disassembled.The basket formation could be manually actuated to fully open and closed positions.The handle was reset and reassembled; the basket formation still doesn¿t appear to fully open, the width of the basket formation is 1 cm.Per drawing e4843 ver 41, the width of the basket formation is 1.0 cm +/- 2mm.According to the drawing, the width of the basket formation is correct.There is no indication that a design or process related failure mode contributed to this event.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, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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