As reported, during a ureteroscopy, the basket of an ngage nitinol stone extractor would not open.A wire where the handle connects appeared broken.A new ngage nitinol stone extractor was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not experience a delay or require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
|
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Correction: h6 (annex g).Event summary as reported, during a ureteroscopy, the basket of an ngage nitinol stone extractor would not open.A wire where the handle connects appeared broken.A new ngage nitinol stone extractor was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not experience a delay or 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), the instructions for use, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned device: device was returned coiled in open packaging without the shipping tray.Basket sheath is damaged approximately 9mm from end of support sheath.The handle does not actuate basket assembly.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 two other complaints associated with the complaint device lot.The two complaints were determined to be unrelated as one device had sheath damage and the other device did not.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: important: excessive force could damage device.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 9mm from the distal end of the yellow support sheath, preventing the basket from opening.The cause of the sheath damage 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.
|