{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. D4 UDI# : (B)(4)." }, { "mdr_text_key": "256559339", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT A SURGEON WAS PERFORMING AN SEEG CASE. WHILE POSITIONED ON THE FIRST TRAJECTORY, LF1C-CB, THE ROSA SOFTWARE SHUTDOWN, RETURNED TO THE ROSA BRAIN HOME SCREEN AND DISCONNECTED THE CONTROLLER. BECAUSE OF AN EARLIER, ALREADY REPORTED ISSUE, THE PATIENT FOLDER WAS NOT ABLE TO BE REOPENED AND PATIENT REGISTRATION HAD TO BE PERFORMED AGAIN. THIS CAUSED AROUND A 45 MINUTE DELAY TO THE CASE, ADDITIONAL ANAESTHETIC WAS PROVIDED TO THE PATIENT. ONCE REGISTRATION WAS REDONE, CASE PROCEEDED AS EXPECTED." }, { "mdr_text_key": "325714170", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SURGEON WAS PERFORMING AN SEEG CASE. WHILE POSITIONED ON THE FIRST TRAJECTORY, LF1C-CB, THE ROSA SOFTWARE SHUTDOWN, RETURNED TO THE ROSA BRAIN HOME SCREEN AND DISCONNECTED THE CONTROLLER. BECAUSE OF AN EARLIER, ALREADY REPORTED ISSUE, THE PATIENT FOLDER WAS NOT ABLE TO BE REOPENED AND PATIENT REGISTRATION HAD TO BE PERFORMED AGAIN. THIS CAUSED AROUND A 45 MINUTE DELAY TO THE CASE, ADDITIONAL ANAESTHETIC WAS PROVIDED TO THE PATIENT. ONCE REGISTRATION WAS REDONE, CASE PROCEEDED AS EXPECTED." }, { "mdr_text_key": "325714171", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE UNEXPECTED RESTART OF THE DEVICE DURING THE PROCESS IS DUE TO THE VIRTUAL MEMORY MISMANAGEMENT. THIS ISSUE WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/27/2021" } ] }