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 and the basket formation also in the open position.The collet knob is tight and secure.The male luer lock adaptor (mlla) is tight.The polyethylene terephthalate tubing (pett) measures 3 cm in length and was returned on the outside of the cannulated handle.When the handle was actuated, the support sheath and the basket sheath were found to be separated.There is minimal adhesive on the basket formation.No damage was noted on the basket sheath.The basket assembly can be manually actuated.The device history record was reviewed and noted two non-conformances were identified.One issue was related to component, missing and the second issue basket/grasper will not open/close.A review of complaint history revealed this is the only complaint associated with lot number 8164308.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 and device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established at this time.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.
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