The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The returned sample was visually and functionally evaluated on a calibrated console.Inspection of the sample found no obvious defects that would have contributed to the reported event.The cassette was tested on a console, primed and tuned with the ultrasonic hand piece successfully and could achieve maximum vacuum.No system message was generated during functional testing.No fluid or air leaks, and no cracks were observed from the connectors.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution bottle through the irrigation path continuously, no fluidic anomalies were observed.No occlusion or obstruction was identified during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned cassette was evaluated and met specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.The manufacturer internal reference number is: (b)(4).
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