Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected information: h6: component code (annex g).Event description: as reported, an ncircle delta wire tipless stone extractor was unable to be opened prior to patient contact.A new device was used to complete the procedure.There was no impact to the patient.Investigation ¿ evaluation a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), manufacturing instructions, the instructions for use (ifu), and quality control data.One ncircle delta wire tipless stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned in its shipping tray inside an open outer package.The handle was in the closed position.The basket formation was in the closed position.The basket sheath was kinked flat 2 mm and 4 mm from the distal tip of the basket sheath - preventing movement of basket assembly.The handle did not actuate basket formation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other similar complaint associated with the complaint device lot.Both devices had similar damage.The results of the investigations of both devices indicated possible handling issues.There was no evidence of a common issue between the two devices that would indicate a possible issue with other devices from the same lot.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 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: 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 basket sheath was kinked in 2 locations near the distal end.The cause for the damage is unknown.The sheath may have been damaged during handling, however no information is known regarding device handling, therefore the cause of the issue could not be conclusively determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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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