Intuitive surgical, inc.(isi) received the illuminator involved with the complaint and completed the device evaluation.Failure analysis confirmed the customer reported.The unit was installed in a test system and it failed to power on; displayed error message.Visual inspection found two blown fuses.This complaint is being reported due to a da vinci system malfunction rendering the da vinci system unavailable 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 cholecystectomy procedure, the customer experienced a non-recoverable system error which came up immediately after connecting the camera cables.The customer restarted the system, power cycled the vision side cart (vsc) breaker, reseated the illuminator, dual camera (doco) connections, and all cables but the issue persisted.The doco was showing blue leds and the illuminator was showing yellow leds.An external light source was used to complete the procedure.An isi field service engineer was dispatched to the facility and was able to reproduce the reported failure.The fse replaced the illuminator which resolved the reported issue.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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