Intuitive surgical inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed the customer reported failure.The unit was installed and tested in the printed circuit assembly (pca) test system.The unit failed with error 1100.Fa applied power to the unit at the test bench and found that power supply was dead and needs to be replaced to resolve the issue.This complaint is being reported due to a da vinci system malfunction 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 cause or contribute to an adverse event.
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It was reported that during a da vinci-assisted adrenalectomy procedure, the customer experienced a recoverable fault that would not recover.The intuitive surgical, inc.(isi) clinical sales representative (csr) contacted the isi technical support engineer (tse) multiple times for troubleshooting assistance.The system would power back on and homed successfully with no errors, however, would continue to have issues with the power.After the third call back, the surgeon decided to convert and complete the procedure using traditional laparoscopic techniques due to the system shutting down multiple times during the procedure.There was no report of patient harm, adverse outcome or injury.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure.To resolve the issue, the fse replaced the core power tray assembly.
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