SCOPEYE

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: (B)(6) (SPINE REP) CALLED IN TO REPORT THAT THE SYSTEM WAS UNABLE TO COMMUNICATE WITH SCOPEYE AND THROUGH THE SCOPEYE LENS, ONLY THE LOGO APPEARED. SPINE REP REPORTED HE ATTEMPTED TO REBOOT BOTH THE STEALTH, TRANSMITTER, AND HEADSET. SPINE REP REPORTED THIS IS A DEMO SYSTEM THAT WAS FUNCTIONING AS INTENDED A WEEK AGO WITH A MAZOR SYSTEM AT ANOTHER SITE. TROUBLESHOOTING: SPINE REP CONFIRMED THAT THE SCOPEYE LOGO APPEARS DURING USE AND DOES NOT GO AWAY. SPINE REP CONFIRMED THAT THE POWER WAS ON TRANSMITTER, CHECKED ALL CONNECTIONS AND CABLES, AND REPORTED THAT THE POWER BUTTON WOULD TURN FROM RED TO WHITE TO LIGHT BLUE BUT THAT THE CONNECTION SYMBOL WOULD ONLY BLINK BLUE IF PRESSED OR REBOOTED BUT NEVER DISPLAYED A SOLID BLUE LIGHT. SPINE REP REPORTED AFTER THE CONNECTION SYMBOL WAS BLINKING BLUE, THE LED WOULD TURN OFF AND NOT ILLUMINATE. SPINE REP REPORTED HE CHANGED THE DISPLAY IN STEALTHSTATION CONFIGURATION TO THE CORRECT HD DISPLAY, LOGGED OUT AND BACK IN AND ISSUE PERSISTED. TS HAD SPINE REP GO INTO STEALTH APPLICATION, SPINE REP CONFIRMED THE EXTERNAL PORT WAS TURNED ON. TS RECOMMENDED SPINE REP ATTEMPT TO PAIR THE SCOPEYE AGAIN HOWEVER, SPINE REP REPORTED THIS IS A DEMO SYSTEM AND HE DOES NOT HAVE THE MANAGER PAD TO PAIR. SPINE REP REPORTED THAT THEY HAVE NOT ATTEMPTED TO DISPLAY ON EXTERNAL MONITOR OR TRANSMIT VIDEO OUT ON THE STEALTH BEFORE. SPINE REP REPORTED HE TRIED TO CONNECT THE SCOPEYE TO THIS SYSTEM AND SYSTEM SN: (B)(6) AND ISSUE PERSISTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).