VALLEYLAB

Additional Manufacturer Narrative

D10 CONCOMITANT PROCUT: VLFT10GEN;VLFT10GEN FT SERIES ENERGY PLATFORMX1; (LOT NUMBER:T2B53752DX) 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 HYSTERECTOMY, WHEN USING A NON MEDTRONIC MONOPOLAR DEVICE AND AFTER TIGHTENING AROUND THE CERVIX, THE FOOT PEDAL IN THE MONOPOLAR SYSTEM ACTIVATED INDEPENDENTLY WITHOUT IT BEING PRESSED BY THE SURGEON. IMMEDIATELY, THE DEVICE CONNECTIONS WERE REMOVED TO CHECK THAT THE DEVICE HAD NOT TOUCHED OTHER ORGANS IN THE ABDOMEN. THE FOOT PEDAL WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT ANY ISSUES. DURING HOSPITALIZATION, THE PATIENT FELT WELL AND WAS LEFT FOR OBSERVATION FOR A FEW MORE ADDITIONAL DAYS. THERE WAS NO PATIENT HARM/INJURY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3 (MFR NAME, STREET 1 AND MFR CITY), D4 (UDI), G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND PHOTOS WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION FOUND NO NOTABLE CONDITIONS. IT WAS REPORTED THAT THE FOOT PEDAL IN THE MONOPOLAR SYSTEM ACTIVATED INDEPENDENTLY WITHOUT IT BEING PRESSED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: MONOPOLAR FOOTSWITCH WAS NOT OPERATING DUE TO THREE INTERNAL CABLES WERE DISCONNECTED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.