SIEMENS SCANNER

Description of Event or Problem

WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED. "WE HAD PROBLEMS SAVING AND SETTING UP IMAGES ON THE SIEMENS SCANNER. XA51 SOFTWARE- LAST PM DONE ON THE IMMRIS WAS IN JANUARY¿. PATIENT WAS SUPINE WITH HEAD TURNED TO THE RIGHT. LOADED SCAN IN VIEW AND GO. FOUND FIBER ON ND IMAGES- SAVED WITH PARREL RANGE BUTTON LOADED DC SCAN- SAVED AXIAL IMAGE NO PROBLEM, WHEN WE SELECTED THE PRESET FOR THE SAGITTAL IMAGE IT DID NOT SHOW THE FIBER IN ANY OF THE SLICES. TRIED MULTIPLE TIMES AND NO CHANGE. TRIED SETTING UP BACK GROUNDS WITH SAVE IMAGES- AXIAL WAS FINE BUT SAGITTAL YOU COULD NOT SEE THE FIBER. WHEN WE DID COPY IMAGE POSITION, THE LINES DID NOT LINE UP TO THE FIBER ARTIFACT, TRIED ADJUSTING LINES TO LINE UP WITH ARTIFACT AND THIS DID NOT HELP. TRIED RUNNING 5 SLICES SCAN AROUND THE FIBER ARTIFACT AND THE FIBER IN THE SAGITTAL PLANE WAS NOT LINED UP. FOUND THAT THE TAPE THAT WAS HOLDING THE COIL CAME LOOSE, THOUGHT MAYBE THE HEAD HAD MOVE. STARTED OVER WITH A NEW 3D SCAN AND FOUND THE FIBERS AGAIN AND HAD THE SAME RESULTS. KEPT RUNNING SCANS SAGITTAL PLANES THAT WERE LINED UP ALONG THE ARTIFACT OF THE AXIAL PLANE UNTIL WE COULD FIND THE FIBER. WAS FINALLY ABLE TO SET UP OUT TMAP AND BG SCANS FROM THEM. HAD NO ISSUES ON THE VISUALASE SYSTEM ONCE WE GOT THE SCANS WE NEEDED TO DO THE CASE." THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).