Additional information provided in d.10, h.3, h.6 and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Two samples were returned for evaluation.The returned samples were visually and functionally evaluated on a calibrated centurion console.Inspection of the sample found no obvious defects that would have contributed to the reported event.The fluidics management system (fms) 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 (bss) 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 fms cassettes were 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.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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