Additional information: 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, the instructions for use(ifu), drawing, manufacturing instructions, and quality control data.The complainant returned one ngage nitinol stone extractor.The returned packaging confirms the reported lot number.The device was returned with the handle in the closed position and the basket formation partially closed.The mlla [male luer lock adapter] is finger tight.The collet knob is tight and secure.Visual exam noted a kink in the basket sheath 88.5 cm from the distal tip.The width of closed basket formation measured 5 mm in width.The polyethylene terephthalate tubing [pett] measures 3.8 cm in length.The basket wires appear stretched and pulled on.Functional test notes the handle actuates the basket formation to the open position, but does not close completely.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history revealed no additional complaints associated with the complaint device lot.The ifu provides the following information to the user related to the reported failure mode: 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.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.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 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 field.Conclusion: the returned device was found to have a basket that would not fully close.It was observed that the wires of the basket were deformed, having the appearance of being pull on.The basket sheath was also kinked.The basket of the device would not fully close due to the damage found on the device.The was no information provided by the user related to handling of the device, but it is possible the damage occurred due to device handling before use.The ifu contains a caution that excessive force could damage the device.All devices are inspected for damage and functionality before packaging.Although it is possible the device experienced handling damage, the specific cause for the complaint could not be determined.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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