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 during a da vinci-assisted partial nephrectomy procedure, the surgeon experienced loss of light and a non-recoverable fault.The technical support engineer (tse) walked the customer through troubleshooting, however, the problem persisted.The customer found an external illuminator and installed it.The surgeon continued with 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 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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