{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3009185973-2019-00385", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20191106", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191008", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20191106", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1080255", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191106", "brand_name": "ROSA BRAIN", "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE", "manufacturer_d_name": "MEDTECH SA", "manufacturer_d_address_1": "ZAC EUREKA", "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT", "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON", "manufacturer_d_state": "", "manufacturer_d_zip_code": "34000", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "FR", "manufacturer_d_postal_code": "34000", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ROSA BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Neurological Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Computer Software Problem", "Computer Software Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/17/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20191106", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20191220", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9283887", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191008", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "310509568", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER AND THE SURGEON WERE TRYING TO UPLOAD A CT TAKEN JUST MINUTES BEFORE AND MERGE THE SCAN WITH THE MRI THAT WAS USED TO PLAN THE SEEG SURGERY. THEY HAD DIFFICULTY MERGING THE TWO SCANS TOGETHER. AS A WORKAROUND, THEY UPLOADED ANOTHER MRI SCAN THAT HAD A DIFFERENT RESOLUTION. THEY WERE ABLE TO MERGE MRI 2 WITH MRI 1, HOWEVER WHEN THEY TRIED THE SAME FOR THE CT SCAN THEY WERE UNABLE TO DO SO. THE SYSTEM HAD AN ERROR MESSAGE \"IMPOSSIBLE TO LOAD EXAM\". IT WAS DECIDED TO DELETE MRI 2 OFF THE ROBOT AND THAT IS WHEN THE SOFTWARE BECAME UNRESPONSIVE SO THEY HAD TO RESTART THE ROBOT/COMPUTER. THIS REBOOT TOOK ABOUT 8 MINUTES. THEY THEN UPLOADED A NEW CT SCAN TO TRY TO MERGE THAT SCAN WITH MRI 1. IT WAS SUCCESSFUL, HOWEVER WHEN THEY SELECTED THE CT HAS THE 3D MODEL IN THE EXAM MANAGER THE ROBOT BECAME UNRESPONSIVE AND THERE HAD TO BE A MANUAL RESTART. THIS REBOOT TOOK ABOUT 8 MINUTES. AFTER THE MANUAL RESTART, THEY UPLOADED AND SUCCESSFULLY MERGED A SECOND CT SCAN. THEY PROCEEDED WITH THE CASE AFTER THE MERGE. THEY PERFORMED A SUCCESSFUL MARKER REGISTRATION AND PERFORMED ALL 10 PLANNED SEEG TRAJECTORIES. THE PATIENT WAS UNDER ANESTHESIA DURING THIS TIME, HOWEVER THE PROCEDURE HAD YET TO START." }, { "mdr_text_key": "310509569", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF SOFTWARE LOGS CONCLUDED THAT THAT MULTIPLE ISSUES OF FUSION OCCURRED DURING THE CASE. ISSUES WERE ALSO FOUND IN THE EXAMS USED FOR THE FUSION PROCESS. IN TOTAL, TWO MAIN CAUSES WERE IDENTIFIED AND A DESIGN DEFECT WAS OPENED. THE DIFFICULTY TO MERGE CT EXAMS WITH THE FIRST MRI USED WAS CONFIRMED. THE AUTOMATIC MERGE IS POSSIBLE BUT PROVIDES AN INCORRECT RESULT WHICH REQUIRES LONG MANUAL ADJUSTMENTS WHICH IMPACTED THE DELAY ON SURGERY. A LARGE PART OF THE MRI WAS INCORRECTLY READ AND DISPLAYED BY THE SOFTWARE. THIS IS A KNOWN ANOMALY THAT IS DUE TO THE MISMANAGEMENT OF THE DICOM CONTRAST. THE SECOND MRI USED, DOES NOT RESPECT THE IFU RECOMMENDATIONS ABOUT IMAGE FORMAT. THE RESOLUTION IS 1024X1024 PIXELS WHICH IS OVER THE MAXIMUM RECOMMENDED. IT IS THE CAUSE FOR THE LOADING ISSUES RELATED TO THIS MRI, ENCOUNTERED DURING THE CASE. THE SECOND CT USED DURING THE SURGERY WAS ABLE TO BE LOADED IN 2D VIEWS BUT FAILED TO BE RECONSTRUCTED AS THE 3D REFERENCE AND PROVOKED THE SOFTWARE CRASH. INDEED, THE ISSUE WAS REPRODUCED ON MANUFACTURING SITE." }, { "mdr_text_key": "166940471", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI#: (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. (B)(4)." }, { "mdr_text_key": "166940472", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER AND THE SURGEON WERE TRYING TO UPLOAD A CT TAKEN JUST MINUTES BEFORE AND MERGE THE SCAN WITH THE MRI THAT WAS USED TO PLAN THE SEEG SURGERY. THEY HAD DIFFICULTY MERGING THE TWO SCANS TOGETHER. AS A WORK AROUND, THEY UPLOADED ANOTHER MRI SCAN THAT HAD A DIFFERENT RESOLUTION. THEY WERE ABLE TO MERGE MRI 2 WITH MRI 1, HOWEVER WHEN THEY TRIED THE SAME FOR THE CT SCAN THEY WERE UNABLE TO DO SO. THE SYSTEM HAD AN ERROR MESSAGE \"IMPOSSIBLE TO LOAD EXAM\". IT WAS DECIDED TO DELETE MRI 2 OFF THE ROBOT AND THAT IS WHEN THE SOFTWARE BECAME UNRESPONSIVE SO THEY HAD TO RESTART THE ROBOT/COMPUTER. THIS REBOOT TOOK ABOUT 8 MINUTES. THEY THEN UPLOADED A NEW CT SCAN TO TRY TO MERGE THAT SCAN WITH MRI 1. IT WAS SUCCESSFUL, HOWEVER WHEN THEY SELECTED THE CT HAS THE 3D MODEL IN THE EXAM MANAGER THE ROBOT BECAME UNRESPONSIVE AND THERE HAD TO BE A MANUAL RESTART. THIS REBOOT TOOK ABOUT 8 MINUTES. AFTER THE MANUAL RESTART, THEY UPLOADED AND SUCCESSFULLY MERGED A SECOND CT SCAN. THEY PROCEEDED WITH THE CASE AFTER THE MERGE. THEY PERFORMED A SUCCESSFUL MARKER REGISTRATION AND PERFORMED ALL 10 PLANNED SEEG TRAJECTORIES. THE PATIENT WAS UNDER ANESTHESIA DURING THIS TIME, HOWEVER THE PROCEDURE HAD YET TO START." } ], "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": "12/23/2019" } ] }