The intuitive surgical, inc.(isi) technical support engineer (tse) viewed system logs and confirmed multiple 607 faults pointing to the personality module surgeon console (pmsc) in the surgeon side console (ssc) during troubleshooting.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the pmsc to resolve the issue.The system was tested and verified as ready for use.Isi received the pmsc involved with this complaint and completed the evaluation.Failure analysis investigation replicated the reported failure.This unit was installed into the test system and it failed with error 607 due to audio test.Audio manager received an invalid audio.Further troubleshooting found that the surgeon audio leaf (sal) board was the cause of the issue.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: system unavailability after the start of a surgical procedure (first port incision) resulted in the procedure being converted to laparoscopic for completion.Although there was no patient harm that resulted, if the malfunction were to recur, it could cause or contribute to an adverse event.
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It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, recoverable fault 607 for audio appeared.The robotics coordinator called in to report the error.The patient was in the room, ports were placed, but system was not docked.She stated that they tried power cycling the system but the fault returned.The technical support engineer (tse) viewed system logs and confirmed multiple 607 faults pointing to the personality module surgeon console (pmsc) in the surgeon side console (ssc).The tse recommended performing a hard power cycle on the ssc.Customer performed this but the error returned.The tse had the customer silence the alarm and press the recover button.The customer performed this and as soon as the recover button was pressed, the fault immediately returned.The tse had the customer perform one more hard power cycle on the ssc with turning the breaker off and unplugging the ssc power cord for over one minute.The customer performed this and as soon as the system powered back on, the fault immediately returned.Customer stated that the surgeon is going to perform the procedure laparoscopically.The procedure was completed laparoscopically with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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