Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, drawings, manufacturing instructions, quality control data, and specifications was also performed.One device was returned for investigation.The device was returned with the handle in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 1.5 cm.A visual examination noted a kink in the basket sheath 38 cm from the distal tip of the basket sheath.A functional test noted the handle does not actuate the basket formation.The basket formation was found to appear collapsed.The knot at the end of the basket formation has come loose.The device history record was reviewed and found there were three non-conformance issues noted.Three items found with basket shape incorrect, three failed test, tensile, non-destructive and one item with labels applied incorrectly.A review of complaint history revealed that this is the only complaint associated to lot number 8170355.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A definitive root cause cannot be established with the information available.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.
|