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, AT THE START OF THE PROCEDURE AFTER DROPPING THE BLADDER, THE SECURE CADIERE FORCEPS (SCF) WAS RETRACTING TISSUE BUT WAS NOT GRASPING IT. THE SURGEON USED THE OTHER HAND AND A MARYLAND INSTRUMENT TO REMOVE THE TISSUE FROM THE SCF, AND THE INSTRUMENT WAS REMOVED USING THE INSTRUMENT DRIVE UNIT (IDU) AS NORMAL. ADDITIONALLY, THE SCF HAD AN INSTRUMENT ERROR WITH A RED ALARM. THE SCF WAS THEN REPLACED WITH A NEW INSTRUMENT TO RESOLVE THE ISSUE AND THE PROCEDURE CONTINUED. THERE WAS A 10-MINUTE DELAY. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

H3) DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE ASSOCIATED DEVICE LOGS FOR THE REPORTED SECURE CADIERE FORCEPS. THE SECURE CADIERE FORCEPS SAMPLE WAS NOT MADE AVAILABLE FOR THIS INCIDENT. EVALUATION OF THE LOGS INDICATED THAT THE SECURE CADIERE FORCEPS WAS CONNECTED TO A STERILE INTERFACE MODULE (SIM) WHEN AN ERROR CODE FOR 'INSTRUMENT USAGE READ WRITE READ SEQUENCE' WAS OBSERVED. THE LOGS ARE NOT ABLE TO CONFIRM IF A GRASPING ERROR OCCURRED AS THIS IS ASSOCIATED WITH A HARDWARE ISSUE. EVALUATION OF THE SECURE CADIERE FORCEPS CONFIRMED THE REPORTED CONDITION, HOWEVER, THE INVESTIGATION CONCLUDED THERE WERE NO ABNORM ALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION; THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE COULD BE TRACED TO A CONNECTIVITY ISSUE BETWEEN THE INSTRUMENT AND SIM. 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, AT THE START OF THE PROCEDURE AFTER DROPPING THE BLADDER, THE SECURE CADIERE FORCEPS (SCF) WAS RETRACTING TISSUE BUT WAS NOT GRASPING IT. THE SURGEON USED THE OTHER HAND AND A MARYLAND INSTRUMENT TO REMOVE THE TISSUE FROM THE SCF, AND THE INSTRUMENT WAS REMOVED USING THE INSTRUMENT DRIVE UNIT (IDU) AS NORMAL. ADDITIONALLY, THE SCF HAD AN INSTRUMENT ERROR WITH A RED ALARM. THE SCF WAS THEN REPLACED WITH A NEW INSTRUMENT TO RESOLVE THE ISSUE AND THE PROCEDURE CONTINUED. THERE WAS A 10-MINUTE DELAY. THERE WAS NO PATIENT INJURY.