HUGO¿ RAS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PARTIAL NEPHRECTOMY, AN INSTRUMENT ERROR WAS TRIGGERED FOR THE MONOPOLAR CURVED SHEARS (MCS) 15 MINUTES INTO TELE-OPERATION. THE INSTRUMENT ERROR OCCURRED 1 HOUR AND 44 MINUTES AFTER SYSTEM STARTUP. A COMMUNICATION ERROR WAS TRIGGERED FOR THE SURGEON CONSOLE (SC) APPROXIMATELY 7 SECONDS AFTER THE INSTRUMENT ERROR WAS DISPLAYED. A VEIN WAS BEING HELD WHEN THE COMMUNICATION ERROR WAS DISPLAYED. DIRECTLY AFTER THE COMMUNICATION ERROR, A PARTIAL ALARM FAILURE ERROR WAS TRIGGERED. THE ISSUE WAS RESOLVED BY RELEASING THE VEIN FROM THE BEDSIDE, WITHDRAWING THE MCS, THEN RESTARTING THE SC. THERE WAS A DELAY OF APPROXIMATELY 15 MINUTES. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.