Intuitive surgical, inc (isi) received the unit involved with this complaint and completed the device evaluation.The reported failure (error 23025 along axis 7/yaw) was able to be reproduced during visual inspection.There was evidence of contamination/corrosion on the embedded serializer master yaw-axis (esmy) and the axis 7 motor.The esmy pca and axis 7 motor were replaced to fix this issue.This complaint is being reported due to a da vinci surgical 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 nephrectomy procedure, the intuitive surgical, inc.(isi) clinical training associate (cta) experienced repeated recoverable faults.The cta powered cycled the system but the error continued.The cta then performed a hard power cycle and disabled the left master tool manipulator (mtm) but the issue persisted.The surgeon moved to the second surgeon side console (ssc) 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 confirmed multiple errors 23017 in the error logs.The fse replaced the gimbal to resolve the issue.The gimbal is the wrist portion of the mtm.
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