A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was reproduced during field evaluation.The fse noticed the patient side manipulator (psm) led was red.An error message displayed on the vision side cart (vsc), but it was continuously changing.The surgeon side console (ssc) appeared to have shut down.The led on the blue fiber cable was not lit.The fse switched to another wall socket and restarted the system, and the system was working normally.Approximately 30 minutes later, the ssc reportedly "crashed automatically like it lost ac power".The system prompted errors 25326, 309, and 25303, and a message displayed indicating to restart the system.The fse confirmed the ac power was good but suspected the issues were coming from the ssc.Per review of the logs, the fse noticed error 417 during every startup and error 25580 from the remote arm controller (rac).The errors were recovered, but the ssc shut down suddenly, and the system prompted error 25326 on the vsc.The fault was suspected to be caused by the medical grade power supply (mgps).The mgps was replaced.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the mgps involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The unit was visually inspected, and the fan was noted to be dusty.The power supply was installed into the printed circuit assembly (pca) system and the ssc powered on with error 417.Noise was observed from fan #2.The unit will be sent to the original equipment manufacturer (oem) to replace fan #2.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the site's system logs for the reported procedure date was conducted by the fse.Investigation revealed the related system errors 417, 25580, and 25326.Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
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It was reported that during a da vinci-assisted surgical procedure, non-recoverable errors 25326 and 25303 were observed.The leds on the patient side manipulators (psm) were red, and the vision in the surgeon side console (ssc) was black.The system was restarted with no resolve.The procedure was converted to laparoscopic surgery with no reported injury.On 04-january-2021, intuitive surgical, inc.(isi) obtained the following additional information from the customer: the system was used approximately 30 minutes before the issue occurred.The system functionality was checked upon powering on and there were no errors.The customer contacted the field service engineer (fse) when the issue occurred, and the fse informed that the system needed to be inspected.The fse went to the customer site and noted the system could not operate normally.Patient demographic information was requested, but the site was unwilling to provide the information.
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