Investigation - evaluation: visual inspection and functional testing of the returned device was conducted during the investigation.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.A functional test determined the device fails to actuate.The basket assembly would not move.There were no kinks or damage to the sheath.The basket was able to be opened using a large amount of force.Once open, the basket would not retract when the handle was released.The cause for the handle sticking and preventing proper operation of the basket could not be determined.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Current controls are in place in manufacturing to assure device functionality prior to shipping.The device history record was reviewed and found there were no non-conformances associated with the complaint device lot number.A review of complaint history revealed this is the only complaint report associated with complaint device lot number 7889809.Based on the provided information a definitive cause issue could not be established.Per the quality engineering risk assessment, no further action is required.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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