HUGO¿ RAS SYSTEM

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, AFTER DOCKING, WHEN THE SECURE CADIERE FORCEPS (SCF) WAS INSERTED, IT WAS INITIALLY RECOGNIZED BY THE SYSTEM BUT THEN DISAPPEARED FROM THE INSTRUMENT BAR. NEW SCF AND SIM WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H3 AND H6: ANNEX B, ANNEX C AND ANNEX G HAVE BEEN UPDATED. DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE ASSOCIATED DEVICE DATA FOR THE REPORTED SECURE CADIERE FORCEPS (SCF). EVALUATION OF THE DEVICE DATA INDICATES THE USE OF SCFS WITH SNS (B)(6) AND (B)(6) ON ARM CART ASSEMBLY 1, BUT DOES NOT SHOW USE OF THE REPORTED SCF WITH SN (B)(6) . EVALUATION OF THE DEVICE DATA FOR THE REPORTED SECURE CADIERE FORCEPS NOTED NO ABNORMALITIES ASSOCIATED WITH THE REPORTED CONDITION. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE. HOWEVER, THE MOST LIKELY ROOT CAUSE CAN BE TRACED TO A FAILURE ON A SEPARATE COMPONENT OF THE SYSTEM. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, AFTER DOCKING, WHEN THE SECURE CADIERE FORCEPS (SCF) WAS INSERTED, IT WAS INITIALLY RECOGNIZED BY THE SYSTEM BUT THEN DISAPPEARED FROM THE INSTRUMENT BAR. NEW SCF AND SIM WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.