{ "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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THE PATIENT WAS PUT UNDER ANESTHESIA, BONE FIDUCIALS WERE PLACED, AND PATIENT WAS SENT DOWN TO CT. WHEN CT WAS COMPLETED, SURGEON ATTEMPTED TO LOAD CT INTO ROSA PLANNING STATION. THE SERIES CONTAINED MORE THAN 255 SLICES. THE ROSA PLANNING SOFTWARE SHUT DOWN. WHEN THE SURGEON ATTEMPTED TO RESTART, THE PATIENT FOLDER WAS NO LONGER VISIBLE. SURGEON WAS DELAYED IN STARTING SEEG BY 1 HOUR, WITH PATIENT UNDER ANESTHESIA. SURGEON CONTACTED A FIELD SERVICE ENGINEER FOR PHONE SUPPORT DURING ISSUE." }, { "mdr_text_key": "310650507", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO LOAD THE PATIENT FOLDER AFTER A DEVICE SHUTDOWN. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE SHUTDOWN OF THE DEVICE WAS A NORMAL BEHAVIOR. WHEN REBOOTING THE DEVICE, THE PATIENT FOLDER COULD NOT BE RETRIEVED BECAUSE IT DID NOT CONTAIN THE CORRECT COMPUTED CRC CODE. NO MORE EVIDENCE PERMITS TO EXPLAIN WHY, ALTHOUGH THE TRAJECTORIES PREVIOUSLY ENTERED AND RENAMED BY THE USER WERE PROPERLY SAVED, THE NEW CRC CODE WAS NOT SAVED CORRECTLY. IT IS A PATIENT FOLDER SAVING ISSUE WHOSE ROOT CAUSE REMAIN UNDETERMINED. CORRECTED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE MANUFACTURER DATE. DEVICE EVALUATED BY MANUFACTURER. EVENT PROBLEM AND EVALUATION CODES." }, { "mdr_text_key": "147443102", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "147443103", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CREATED AND PLANNED 13 TRAJECTORIES FOR CASE. PATIENT WAS PUT UNDER ANESTHESIA, BONE FIDUCIALS WERE PLACED, AND PATIENT WAS SENT DOWN TO CT. WHEN CT WAS COMPLETED, SURGEON ATTEMPTED TO LOAD CT INTO ROSANNA COMPUTER FOR PRE OP PLANNING. THE SERIES CONTAINED MORE THAN 255 SLICES. THE ROSANNA PLANNING SOFTWARE SHUTDOWN. WHEN THE SURGEON ATTEMPTED TO RESTART, THE PATIENT FOLDER WAS NO LONGER VISIBLE. SURGEON WAS DELAYED IN STARTING SEEG BY 1 HOUR, WITH PATIENT UNDER ANESTHESIA. SURGEON CONTACTED A FIELD SERVICE ENGINEER FOR PHONE SUPPORT DURING ISSUE." } ], "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": "06/13/2019" } ] }