SITUATE

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROBOTIC CASE, IT WAS NOTICED THAT THE CHIP/RF (RADIO FREQUENCY) TAG HAD FALLEN OUT OF THE RAYTEC AFTER PULLING THROUGH THE TROCAR. THE PATIENT WAS BROUGHT BACK TO THE OR (OPERATING ROOM), X-RAY WAS PERFORMED AND ULTIMATELY REMOVE THE CHIP VIA LAPAROSCOPICALLY. PHOTO RECEIVED SHOWED THAT THE GREEN POUCH FOR THE RF TAG WAS FRAYED AND HAD A HOLE.

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.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE GREEN POUCH HAD A HOLE IN IT, AND THE SIDES OF THE HOLE WERE FRAYED. THERE WERE TWO SMALLER AREAS THAT WERE ALMOST FRAYED, BUT THOSE TWO AREAS WERE NOT HOLES. FUNCTIONAL TESTING NOTED THAT THE STITCHING AROUND THE GREEN POUCH WAS INTACT AND ADEQUATELY SEWN. THE TAG WAS MISSING AND WAS NOT RETURNED. THE POUCH APPEARED TO HAVE BEEN CAUGHT ON SOMETHING, SUCH AS THE TROCAR EDGE OR AN INSTRUMENT. IT WAS REPORTED THAT DURING A ROBOTIC CASE, IT WAS NOTICED THAT THE CHIP/RF (RADIO FREQUENCY) TAG HAD FALLEN OUT OF THE RAYTEC AFTER PULLING THROUGH THE TROCAR. THE REPORTED ISSUE WAS CONFIRMED. 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. 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.