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 wet returned sample was visually inspected and no obvious defects were observed that would have caused or contributed to the reported event.A calibrated console was used to sample and the fluidics management system (fms) cassette primed and tuned with the handpiece successfully and could achieve maximum vacuum.No system message was generated, no fluid or air leaks, and no cracks were observed on the connectors that would have contributed to the reported event.The irrigation and aspiration flow rates were measured and found to be within specifications.Fluid flowed from the balanced salt solution (bss) bottle to the irrigation and aspiration manifolds and continuously to the cassette housing.No occlusion or obstruction was observed during inspection and functional testing.The root cause of the customer's complaint could not be established as the returned fms 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.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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