Event summary: cook was informed of an incident involving a ncircle tipless stone extractor.The device reportedly was found to have a basket that would not open before during a ursl procedure.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.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, drawing, the instructions for use, manufacturing instructions, and quality control data.The device was returned in the shipping tray in an open outer package.The device had the handle and the basket formation in the closed position.The mlla (male luer lock adapter) and collet knob were tight and secure.The polyethylene terephthalate tubing [pett] measured 2.5 cm in length.There were no kinks in the basket sheath.Functional test determined the handle does not actuate the basket formation.The handle was disassembled during investigation and reset and reassembled.After reset, the handle did actuate the basket formation normally.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.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.No damage to the device was noted.The handle was disassembled and the basket could be manually opened and closed by manipulating the proximal end of the basket assembly.The device was reassembled and normal basket function was restored.A cause for the failure of the basket to open 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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