The lot complaint history was reviewed, this is the third 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 used sample was visually inspected.The drip chamber was cut off from the administration manifold.Replacing the administration manifold from the lab stock, the sample was tested using a calibrated console.The sample could prime and tune with the ultrasonic handpiece successfully.The irrigation and aspiration pressure were measured at multiple set points and met specifications.No message code appeared on the screen.The maximum value of vacuum and continuous reflux displayed properly on the progress bar.Fluid flowed from balanced salt solution (bss) to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test was completed.The sample passed functionality.The root cause of the customer's complaint could not be established; the returned sample functioned per 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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