It was reported, during a ureteroscopy, a ngage nitinol stone extractor (reference this report) and a ncircle tipless stone extractor (reference patient identifier (b)(6)) were used.While extracting small stones from the kidney, the device quit working during the case.The device worked initially, then eventually quit working.The procedure was completed with another extractor.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
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Event description: as reported, during a ureteroscopy, a ngage nitinol stone extractor (reference this report) and a ncircle tipless stone extractor (reference patient identifier 314112) were used.While extracting small stones from the kidney, the device quit working during the case.The device worked initially, then eventually quit working.The procedure was completed with a third extractor.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.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 ngage nitinol stone extractor was returned for investigation.Inspection of the returned device noted: the device was returned with the handle in the open position and the basket formation in the closed position.The mlla [male luer lock adapter] was tight.The collet knob was tight and secure.The polyethylene terephthalate tubing [pett] measured 3.5 cm in length.There were three broken wires in the basket formation.A functional test determined the handle actuates the coil assembly, the basket formation did not open due to the broken wires.There were no major kinks in the basket sheath.The support sheath was slightly bowed.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 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 100% 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: suggested handling instructions for extractors and forceps caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.Store in a dark, cool, dry place.The returned device was found to have a damaged basket.The basket wires had separated from the basket sheath that holds them in place, preventing the basket from opening when the handle was functioned.Devices are inspected for damage and functionality prior to packaging.The device likely became damaged during handling / use of the device.The ifu contains cautions about manipulating the device to prevent damage.There was no information related to product handling provided.Cause of the reported issue could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.The appropriate personnel were 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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