Additional information: b5, d9, d10, e4, h3.E1: name and address: postal code - postal code:(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a flexible ureteroscopy, the basket on a ngage nitinol stone extractor malfunctioned during the procedure.The device was partially disassembled while being used leaving loose wires out of the basket.They had to cut the wires off at the handle to protect the inner lumen.There was no damage noted to the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, 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 of the returned complaint device was also conducted.The device was returned to cook in an open package with label.Upon removing from the package, the device was in 4 pieces and the basket appeared to be broken.All the basket wires were pulled free from the basket sheaths that normally hold the wires in place.The basket sheath and basket assembly had been cut off at the handle.Due to the device being broken into multiple pieces, a function test could not be conducted.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the 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) provides the following information to the user related to the reported failure mode: important: "excessive force could damage device." based upon the available information and results of the investigation, cook has concluded that the cause for the damage to the basket wires could not be determined.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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