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As reported, during retrograde intrarenal surgery (rirs), a laser was used to break up the stone, prior to using an ngage nitinol stone extractor to extract stones.The device was able to be used two to three times to extract stones, however, the handle to open and close the basket was "tight".A basket wire broke while opening the basket inside the calyx, trying to capture a less than a 5mm stone.No part of the basket separated inside the patient.The device was removed from the patient and a new basket was used to complete the case.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: annex g.Summary of event: as reported, during retrograde intrarenal surgery (rirs), a laser was used to break up the stone, prior to using an ngage nitinol stone extractor to extract stones.The device was able to be used two to three times to extract stones, however, the handle to open and close the basket was "tight".A basket wire broke while opening the basket inside the calyx, trying to capture a less than a 5mm stone.No part of the basket separated inside the patient.The device was removed from the patient and a new basket was used to complete the case.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Corrected information: h6 (annex g).Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the returned complaint device was also conducted.The complaint device was returned to cook in the open condition in the packaging tray.The handle did not actuate the basket formation fully and one of the 3 basket wires was broken.The broken ends of the basket wire did not show evidence of exposure to a laser or other electrified device.The handle was disassembled, however, the basket formation could not be actuated manually.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history found 3 possibly related complaints, however, the manufacturing process for the basket device is individual in nature, and there is not enough evidence to conclude that the other devices in the lot may be non-conforming.Because there were no related non-conformances, adequate inspection activities had been established, and there was objective evidence that the dhr was fully executed, it was concluded that there was no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing and quality control documents was conducted.All extractors are verified to assure the basket opens and closes properly.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) does not provide any information related to the reported issue.Based upon the available information, cook has concluded that the cause for the issue could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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