The phaco handpiece was received and a visual assessment of the returned sample found no nonconformities.The returned phaco handpiece was connected to an ophthalmic system.The phaco handpiece tuned successfully; however, system message (sm) [u/s hp failure - handpiece voltage low (short circuit)] displayed when attempting a five minute burn-in with the system set at 100% ultrasonic and torsional power.During the burn-in test, the temperature of the phaco handpiece was measured and was found to be within specifications.Disassembling the handpiece revealed moisture ingress within the electrode chamber.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event of the phaco handpiece not working can be attributed to moisture ingress causing the high electrode to short to ground; however, how or when moisture entered the handpiece remains inconclusive.The phaco handpiece was found to exhibit no problems as related to the reported event of the handpiece heating up; therefore, the root cause of the reported event cannot be determined conclusively.Manufacturer 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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