Intuitive surgical, inc.(isi) received the illuminator involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.A visual inspection was performed and the front of the unit was found to be clogged with dust.The unit was installed into a test system and it failed to power on with an error 48238.The 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 tubal reanastomosis surgical procedure, the illuminator light would not turn on.The site tried from the camera head and the touchscreen with no change.The intuitive surgical, inc (isi) technical support engineer (tse) instructed the customer to use an external light source to complete 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.The fse removed and 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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