The isi fse replaced two fiber cables to resolve the issue experienced by the customer.However, the fiber cables will not be returned to isi for failure analysis as these cables were scrapped in the field.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 surgical procedure, the system generated a continuous non-recoverable 319 fault.The customer attempted troubleshooting by removing instruments and performing two system reboots with no change.The customer stated that one of the instruments had to be removed using an emergency release wrench.The intuitive surgical, inc.(isi) technical support engineer (tse) was able to confirm the 319 errors in the logs reported by the patient cart gantry indicating nodes not responding.The tse continued to troubleshoot with the customer but the issue persisted.At that time, the customer made the decision to convert and complete the procedure using traditional laparoscopic techniques.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 replaced the two fiber cables to resolve the issue.
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