ATAMA SYSTEM

Description of Event or Problem

(B)(4) SOFTWARE GENERATED ERRORS DURING THERMOMETRY MONITORING THAT PREVENTED TREATMENT. THE ERROR CODE: NOISY IMAGE DETECTED D EXCEEDS THRESHOLD WAS PERSISTENT ACROSS THE ATTEMPTED TREATMENT, AND WAS NOT RESOLVED UNTIL A NEW TRAJECTORY WAS USED. THE INITIAL TRAJECTORY WAS A LATERAL TRAJECTORY, HOWEVER, THE MONITORING PLANES WERE COMPLETELY INSIDE BRAIN TISSUE AND NO IMMEDIATE CAUSE COULD BE DETERMINED. UPLOADED THE TREATMENT PROFILES FOR DEVELOPMENT REVIEW.

Additional Manufacturer Narrative

THE ATAMA COIL IS CONSIDERED CAPITAL EQUIPMENT, AND IS THEREFORE REUSABLE. INITIAL REPORT DID NOT INDICATE THAT A DEVICE MALFUNCTION HAD OCCURRED, ONLY THAT SOFTWARE GENERATED ERRORS. INDEPENDENT OF THIS FACT, THE CASE WAS SUCCESSFULLY COMPLETED. UPON INSPECTION OF THE ATAMA COIL AT THE HOSPITAL BY MONTERIS PERSONNEL ON (B)(4) 2012, IT WAS FOUND THAT THE COIL WAS NOT OPERATING PROPERLY. THE MALFUNCTIONING COIL WAS REMOVED AND REPLACED. THE MALFUNCTIONING COIL IS TO BE RETURNED TO MONTERIS FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE PROVIDED AT THAT TIME.

Additional Manufacturer Narrative

THE ATAMA COIL IS CONSIDERED CAPITAL EQUIPMENT, AND IS THEREFORE REUSABLE. INITIAL REPORT DID NOT INDICATE THAT A DEVICE MALFUNCTION HAD OCCURRED, ONLY THAT SOFTWARE GENERATED ERRORS. INDEPENDENT OF THIS FACT, THE CASE WAS SUCCESSFULLY COMPLETED. UPON INSPECTION OF THE ATAMA COIL AT THE HOSPITAL BY MONTERIS PERSONNEL ON (B)(4) 2012, IT WAS FOUND THAT THE COIL WAS NOT OPERATING PROPERLY. THE MALFUNCTIONING COIL WAS REMOVED AND REPLACED. THE MALFUNCTIONING COIL IS TO BE RETURNED TO MONTERIS FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE PROVIDED AT THAT TIME.