The company service representative examined the system but was unable to replicate the reported event of the laser power being low.The company service representative tested and verified the laser power output and found it to meet product specifications.The company service representative was able to replicate the reported event of the sm.The company service representative observed sm (illuminator ballast thermo-cut-off has been triggered.Illuminator functions will be disabled.) in the system and was unable to clear it.The root cause of the sm is likely due to a nonconforming table top illuminator.However, a replacement illuminator cannot be replaced at that time.The company service representative tested and verified the auxiliary illuminator and found it to perform as intended.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The fragmatome handpiece was received and a visual assessment of the returned sample found no nonconformities.The returned sample was connected to a calibrated system.The handpiece tuned successfully and completed a five-minute burn-in test with the system set at 100% ultrasonic and torsional power.The handpiece was connected to dynamic tuning fixture (dtf) for stroke length testing on the longitudinal and torsional movements, which found the handpiece did not meet product specifications.Disassembling the handpiece revealed a twisted low electrode and high electrode.The customer reported event was confirmed, which found twisted low and high electrodes to cause the torsional stroke length of the fragmatome handpiece to not meet product specifications.The fragmatome 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 low laser power cannot be determined conclusively as the system was found to meet specifications.The root cause of the reported event of sm displayed cannot be determined conclusively.The root cause of the fragmatome handpiece was not cutting as expected and had low power, can be attributed to a twisted low electrode and high electrode.The manufacturer internal reference number is: (b)(4).
|