MICOSCOPE, SURGICAL, GENERAL AND PLASTIC SURGERY

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE SYSTEM IS INTEGRATED AND CALIBRATED WITH THE MICROSCOPE AND THE CALIBRATION PASSED. DURING THE PROCEDURE A SHIFT OF ALMOST 6MM ON THE NAVIGATION SYSTEM WAS NOTED FROM THE ACTUAL FOCUS POINT OF THE MICROSCOPE WHERE THE USER WAS FOCUSING. IN THE IMAGES IT WAS NOTED IN THE FIRST TWO IMAGES THAT THE USER WAS FOCUSING ON THE SURFACE OF THE SKULL, HOWEVER THE VIRTUAL MICROSCOPE POINTER CAN BE SEEN MORE THAN 6MM INSIDE THE SKULL. IN THE THIRD IMAGE, THE TWO IMAGES HAVE BEEN CORRELATED. WHEN THE USER WAS IN THE TUMOR CAVITY, IT WAS ASKED TO USE THE PROBE TO LOCATE A POSITION. IT IS EVIDENT FROM THE IMAGES WHAT THE ACTUAL POSITION OF THE PROBE WAS NOT AT ALL CORRELATING WITH THAT OF THE VIRTUAL MICROSCOPE TIP. PER CORRESPONDENCE WITH THE SITE STAFF THE REASON FOR THE INACCURACY IS BECAUSE OF THE FOCUS CALIBRATION OF THE MICROSCOPE. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. CALIBRATION OF THE MICROSCOPE WAS COMPLETED WITH ZEISS REP PRESENT, AND THE NAVIGATION SYSTEM WAS CONFIRMED AS FUNCTIONAL AFTERWARDS. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE NAVIGATION SYSTEM WAS FOUND TO BE ACCURATE AND FULLY FUNCTIONAL. THE MOST LIKELY CAUSE WAS A FOCUS CALIBRATION ISSUE WITH THE ZEISS MICROSCOPE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).