It was initially reported during extraction of kidney stones using the ncircle tipless stone extractor the scrub tech noticed that there was suddenly less tension on the basket lever.The basket would no longer open or close fully and was not as responsive as it should be.A new basket was opened and used.Additional information was received on (b)(6) 2018.During the ureteroscopy with laser lithotripsy procedure using a flexible ureteroscope, the lever and basket broke/separated during prolonged use.Stone was in multiple manageable size fragments.The basket was not responding fully with thumb lever during use, and the yellow sheath on the basket wire separated from near the handle.There were no adverse consequences due to this failure.They simply opened up another device and continued the procedure.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: investigation ¿ evaluation.A visual inspection 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 returned to manufacturer for investigation.Returned packaging confirms lot number 9196648.The device was returned with handle and basket assembly separated.The device handle is in the open position, and the slide moves to open and close positions.The male luer lock adapter (mlla) is loose.The collet knob is tight and secure.The polyethylene terephthalate tubing (pett) measures 2.6 cm in length.Visual examination noted with the handle in the open position, 1.8 cm of the cannulated handle protrudes from the mlla.The support sheath and basket sheath are completely severed 1 mm from the mlla.The basket sheath has seven kinks located at 4mm, 1 cm, 1.5 cm, 35.5 cm, 48.5 cm, 64.2 cm, and 90 cm from the distal tip.Visual examination also notes that 5.5 cm of the coil assembly is protruding from the proximal end of the support sheath.The support sheath and basket sheath are still adhered.The support sheath measures 4.3 cm in length.The coil assembly is severed from the cannulated handle.From the point of separation, the coil assembly is kinked 3 mm from end and is curved starting at 7 mm from end.The basket assembly was removed from the basket sheath.The basket formation and distal cannula are still attached to the coil assembly and remain intact.A review of the device history record found there were no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history records shows that no other complaints have been received on the complaint device lot # 9196648.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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint device was found to have a basket that would not function due to the sheath having separated.The sheath was damaged and separated near the handle, preventing the basket from functioning.All devices are inspected for functionality and damage prior to packaging.The condition of the returned device makes it possible that it was inadvertently damaged during handling / use.The investigation conclusion has been determined to be cause traced to user; unintended use error caused or contributed to the event.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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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