HUGO¿ RAS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SAME ROBOTIC-ASSISTED UTERINE CANCER LAPAROSCOPIC PROCEDURE, THE UPPER ARM DRAPE WAS PINCHED IN BETWEEN THE ACA AND SIM AND DURING ATTEMPTING TO RESEAT THE SIM, A TORQUE ERROR MESSAGE WAS DISPLAYED. THE ARM CART WAS UNPLUGGED, RECONNECTED, AND RECALIBRATED, AFTER WHICH A NEW SIM WAS INTRODUCED AND DOCKING WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT.

Additional Manufacturer Narrative

CONTINUE TO D10: PRODUCT ID: MRASA0003 SN: (B)(6) PRODUCT ID: MRASC0002 SN: (B)(6). 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.