It was reported that while performing a bilateral ureteroscopy w/ laser lithotripsy that during the extraction of the stone, when the basket met the ureteral access sheath, the physician went to pull the basket through the access sheath and the tip of the basket broke off.The reporter stated that there was no lithotripsy being used at the time the basket was in use.It was further reported that there was swelling at the uretero pelvic junction, making it difficult to pull the stone into the access sheath.The basket tip was retrieved with a 3 prong grasper.Another basket was used to complete the procedure.No unintended section of the device remained inside of the patient.There were no further adverse effects to the patient from this event.
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Investigation - evaluation.A review of documentation, drawings, functional testing, manufacturing instructions, specifications, quality control data, and visual inspection of the returned device was conducted during the investigation.The basket formation has been severed from the coil assembly.The complaint was confirmed based on the investigation of returned device.Current controls are in place in manufacturing to assure device functionality prior to shipping.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.There is no indication that a design or process related failure mode contributed to this event.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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