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It was reported, the customer inspected the ngage nitinol stone extractor prior to use to ensure no damage had occurred.The basket function was tested prior to use and was found to be functioning properly.During a transurethral lithotripsy, the basket was deformed and become unable to extract stones.This occurred during the first stone extraction after the ureter/kidney stones had been crushed by a laser.Another same type device was used to complete the procedure.No adverse effects have been reported due to the alleged malfunction.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it was reported, the customer inspected the ngage nitinol stone extractor prior to use to ensure no damage had occurred.The basket function was tested prior to use and was found to be functioning properly.During a transurethral lithotripsy, the basket was deformed and become unable to extract stones.This occurred during the first stone extraction after the ureter/kidney stones had been crushed by a laser.Another same type device was used to complete the procedure.No adverse effects have been reported due to the alleged malfunction.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ngage nitinol stone extractor was returned for investigation with the handle and basket formation in the open position.The male luer lock adapter and collet knob were tight.The polyethylene terephthalate tubing measured 3.5cm in length.Visual exam noted the basket formation appeared deformed with the basket wires buckled.The handle actuated the basket formation, but the basket formation did not fully open.The handle was dissembled, and the basket formation could not be manually actuated.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use which state, ¿excessive force could damage device.¿ as the device was tested prior to use, it is likely the sheath deformation occurred during use of the device.There were two likely causes for the issue: 1) the distal end of the sheath was caught on an unknown object, which pulled the sheath distally.2) the sheath was not properly installed on the basket sheath during manufacturing.A combination of the two causes was also possible.Based on the available information, cook has concluded there was not enough evidence to make a conclusive determination of the cause of the issue.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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