Intuitive surgical, inc.(isi) received the unit involved with this complaint and completed the device evaluation.Failure analysis reproduced the customer reported failure.The illuminator was installed into the system and it failed to power on with errors.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 prior to the start of a da vinci-assisted surgical procedure, an error occurred at startup.The intuitive surgical, inc.(isi) technical support engineer (tse) guided the isi clinical sales representative (csr) through troubleshooting, however, errors persisted.It was recommended to use an external illuminator to continue with the setup.Isi followed up with the reporter and obtained additional information about the complaint.The issue occurred when the patient was being put under anesthesia.The csr believes that additional anesthesia was given due to the time that it took to find an external illuminator.There were no reports of intraoperative or post-operative complications.An isi field service engineer (fse) was dispatched to the facility and was able to reproduce the reported failure and the error was confirmed through the system logs.To resolve the issue the fse replaced the illuminator.The illuminator is a component of the da vinci system that contains a high intensity light source to illuminate the surgical site.
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