It was reported that the physician was performing an intended retrograde intrarenal surgery (rirs) on the left kidney of a patient by using the ngage nitinol stone extractor.While trying to relocate the stone from one calyx to other, the physician found that one of the wires was separated from the basket.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation ¿ evaluation a review of functional test, device history record, complaint history, manufacturing instructions, quality controls, and visual inspection was conducted on the returned device during the investigation.One device was returned for investigation with the unidex handle (udh) and the basket formation in the open position.A functional test noted the udh handle did not actuate the basket formation.A visual examination noted the support sheath bowed to the point of being bent.One of the basket wires was found cut/broken.With the support sheath in the bowed/bent position, the udh handle did not actuate the basket formation, but when the support sheath was straightened out, the udh handle actuated the basket formation to the open and closed positions.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.In addition review of device master record did not observe any nonconformance that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.
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