The phacoemulsification (phaco) handpiece was received.And a visual assessment of the returned phaco handpiece found no visual nonconformities.The phaco handpiece was connected to a resistance test box, where the input and output impedance were found to be within specification.The phaco handpiece tuned successfully.And completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The phaco handpiece was connected to dynamic tuning fixture (dtf), for stroke length testing on the longitudinal and torsional movements, which found the handpiece to meet product specifications.The phaco handpiece manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The phaco handpiece was found to meet specifications.Therefore, the root cause of the reported event cannot be determined the manufacturer internal reference number is: (b)(4).
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