It was reported, during a transurethral lithotripsy using a ncircle tipless stone extractor, the basket would not open properly.The device package was opened and the basket was in the closed position.The user inserted the device into the ureteroscope and attempted to open/close the basket but it failed.It was then discovered that the purple protective sheath was separated from the handle.Another same type device was used to complete the procedure.No adverse events have been reported due to the alleged malfunction.
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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, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted the device was returned with the handle and the basket formation in the open position.The mlla (male luer lock adapter) and collet knob were tight.The polyethylene terephthalate tubing [pett] measured 2.7 cm in length.The support sheath and basket sheath were severed at the nose of the mlla.With the handle in the open position, 2.3cm of the basket assembly was exposed.The remainder of the support sheath and the basket sheath were still adhered.Functional testing determined the handle does not actuate the basket formation.While holding the several points of separation together, the handle will actuate the 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 no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a basket that was closed on could not be opened due to sheath damage.The purple support sheath and basket sheath were separated near the handle.The provided information stated that user was experienced in use of the device and therefore it was unlikely that the issue was caused by handling.All devices are inspected for damage and functionality prior to packaging.A cause for the issue could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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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