Additional information has been provided in d.4., d.9., h.3., h.6.And h.10.Corrected information has been provided in h.6.Patient code.The phaco handpiece was received and a visual assessment of the returned sample found no nonconformities.The returned phaco handpiece was connected to a calibrated system.The phaco handpiece tuned successfully and completed a five-minute burn in test with the system set at 100% ultrasonic and torsional power.The temperature of the phaco handpiece shell was measured and was found to meet specifications.The phaco handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the torsional stroke measurement of the phaco handpiece did not meet product specifications.Disassembling the handpiece revealed moisture ingress within the electrode chamber.There was no problem found with the returned phaco handpiece during testing, as related to the reported event of the handpiece getting hot.The reported event of no phaco power was confirmed through dtf testing which found the phaco handpiece did not meet specifications for the torsional stroke measurement.Disassembling the phaco handpiece revealed moisture ingress within the electrode chamber, however, how or when the moisture entered the phaco handpiece remains inconclusive.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The returned handpiece was found to exhibit no problems as related to the reported event of the handpiece getting hot; therefore, the root cause of the reported event cannot be determined conclusively.The root cause of the reported event of no phaco power can be attributed to moisture ingress causing a short circuit from the high electrode to ground; however, how or when moisture entered the handpiece remains inconclusive.The manufacturer internal reference number is: (b)(4).
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