HUGO¿ RAS SYSTEM

Additional Manufacturer Narrative

H3) EVALUATION SUMMARY: MEDTRONIC LED AN EVALUATION OF THE REPORTED SECURE CADIERE FORCEPS AND THE ASSOCIATED DEVICE LOGS. EVALUATION OF THE LOGS COULD NOT IDENTIFY THE REPORTED SECURE CADIERE FORCEPS. VISUAL INSPECTION OF THE RETURNED SECURE CADIERE FORCEPS NOTED NO CORROSION ON THE ELECTRICAL CONTACTS. THERE WAS NO DAMAGE NOTED TO THE JAWS OR OF THE DRIVE CABLES. FUNCTIONALLY, THE JAWS WERE MANIPULATED INTO MULTIPLE POSITIONS IN ORDER TO INSPECT THE CABLES. THE JAWS WERE ABLE TO ACHIEVE EACH POSITION FULLY WITH NO DIFFICULTY. ELECTRICAL TESTING WAS PERFORMED AND THE SECURE CADIERE FORCEPS WERE READ WITH NO OBSERVED FAILURES. THE USE TIME WAS THREE HUNDRED AND THREE MINUTES, WHICH EXCEEDS THE MAXIMUM USE TIME. EVALUATION OF THE SECURE CADIERE FORCEPS CONFIRMED THE REPORTED CONDITION. THE INVESTIGATION IDENTIFIED THE MOST LIKELY CAUSE COULD BE TRACED TO AN END OF LIFE PROBLEM. 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 THE LYMPHADENECTOMY AND LYMPH NODE SENTINEL DISSECTION FOR A ROBOTIC LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE SECURE CADIERE FORCEPS WAS GRASPING THE TISSUE WHEN THERE WAS AN ERROR ON THE INSTRUMENT SAYING LIFE TIME OF THE INSTRUMENT WAS OVER BUT THE SURGEON STILL DECIDED TO NOT CHANGE IT. THE INSTRUMENT WAS REMOVED WITH SAFETY PROCEDURE. NO ISSUES TO THE PATIENT.

Additional Manufacturer Narrative

H6: ANNEX C HAS BEEN AMENDED. DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE RETURNED SECURE CADIERE FORCEPS (SCF), AS WELL AS THE ASSOCIATED DEVICE DATA. VISUAL INSPECTION OF THE RETURNED SCF NOTED NO CORROSION ON THE ELECTRICAL CONTACTS. THERE WAS NO DAMAGE NOTED TO THE JAWS OF THE I NSTRUMENT. MICROSCOPIC INSPECTION OF THE DRIVE CABLES NOTED NO DAMAGE. FUNCTIONALLY, THE JAWS WERE MANIPULATED INTO MULTIPLE POSITIONS IN ORDER TO INSPECT THE CABLES. THE JAWS WERE ABLE TO ACHIEVE EACH POSITION FULLY WITH NO DIFFICULTY. ELECTRICAL TESTING WAS PERFORMED AND THE INSTRUMENT WAS READ WITH NO OBSERVED FAILURES. THE INSTRUMENT HAD BEEN USED FOR THREE HUNDRED AND THREE MINUTES, WHICH EXCEEDS THE MAXIMUM USE TIME OF TWO HUNDRED AND THIRTY-NINE MINUTES. EVALUATION OF THE DEVICE DATA INDICATES THAT THE PROVIDED PROCEDURE ID DID NOT SHOW USE OF THE REPORTED SCF. 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 THE DEVICE REACHING END OF LIFE. 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 THE LYMPHADENECTOMY AND LYMPH NODE SENTINEL IN GENECOLOGY ROBOTIC LAPAROSCOPIC PROCEDURE, DURING LYMPH NODE DISSECTION, THE SECURE CADIERE FORCEPS (SCF) WAS GRASPING THE TISSUE WHEN THERE WAS AN ERROR ON THE INSTRUMENT SAYING LIFE TIME OF THE INSTRUMENT WAS OVER BUT THE SURGEON STILL DECIDED TO NOT CHANGE IT. THE INSTRUMENT WAS REMOVED WITH SAFETY PROCEDURE. NO ISSUES TO THE PATIENT.

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 THE LYMPHADENECTOMY AND LYMPH NODE SENTINEL IN GENECOLOGY ROBOTIC LAPAROSCOPIC PROCEDURE, DURING LYMPH NODE DISSECTION, THE SECURE CADIERE FORCEPS (SCF) WAS GRASPING THE TISSUE WHEN THERE WAS AN ERROR ON THE INSTURMENT SAYING LIFE TIME OF THE INSTRUMENT WAS OVER BUT THE SURGEON STILL DECIDED TO NOT CHANGE IT. THE INSTRUMENT WAS REMOVED WITH SAFETY PROCEDURE. NO ISSUES TO THE PATIENT.