As reported, during transurethral urinary stone extraction, the purple protective sheath and the basket sheath of an ncircle tipless stone extractor broke and the basket would not open/close.The device was tested prior to use and the basket was found to be functioning properly.The user was able to use the device three times to remove urinary stones from the renal pelvis and renal calyx before this issue occurred.Another same type device was used to complete the procedure.No section of the device detached inside the patient.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.Summary of event: as reported, during transurethral urinary stone extraction, the purple protective sheath and the basket sheath of an ncircle tipless stone extractor broke and the basket would not open/close.The device was tested prior to use and the basket was found to be functioning properly.The user was able to use the device three times to remove urinary stones from the renal pelvis and renal calyx before this issue occurred.Another same type device was used to complete the procedure.No section of the device detached inside the patient.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.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 functional test and visual inspection of the complaint device was also conducted.The device was returned to cook in open inner packaging.The support sheath and basket sheath were separated at distal end of the male luer lock adapter (mlla).Approximately 2 centimeters of inner basket assembly was exposed.The handle did not actuate the basket.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the product labeling.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The returned device was found to have a basket that was closed and could not be opened due to sheath damage.The purple support sheath was separated near the handle.The cause for the damage is unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue could not be conclusively 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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