The lot complaint history was reviewed, this is the tenth 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 inspected and there were no obvious defects observed that would have contributed to the reported event.A full product pressure leak test was then conducted on the cassette utilizing an external pressure source and no leakage was detected.A calibrated console representing a current software version was then used to test the sample.The sample could prime, and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.No leakage was detected from the manifolds, connectors, or drain path between the consumable and console.After functional testing no leakage was detected from the pump elastomer or on the pump area of the fluidics module.The presence of fluid leaking from the cassette was not confirmed.After both leakage and console laboratory testing, inspection of the sample indicated no signs of continued leakage from the pump elastomer or cassette.Furthermore, there were no signs of fluid leakage onto the fluidics console due to leakage from the cassette.The cassette passed functional and performance testing.This complaint has been reviewed and the sample was found to be conforming, therefore no further actions will be pursued at this time.The manufacturer internal reference number is: (b)(4).
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