{ "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": "3009185973-2019-00421", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20191128", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191030", "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": "20191128", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1184974", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191128", "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 3.0", "catalog_number": "ROSA BRAIN", "lot_number": "3.0.0.21", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20191128", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20191128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9390453", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191030", "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": "168457805", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED, THIS ANALYSIS CONCLUDED THAT THE AUTOMATIC SCAN COULD NOT BE PERFORMED BECAUSE TOO MANY POINTS WERE INACCESSIBLE BECAUSE THE PATIENT HEAD WAS POSITIONED TOO FAR FROM THE ROBOT. THEN, THE FIRST COMMUNICATION FAILURE WAS DUE TO A CONTROLLER ERROR, HOWEVER, ITS TYPE CANNOT BE DETERMINED BECAUSE AN ISSUE OCCURRED DURING THE DATA RECORD AND DATA CONCERNING THIS ISSUE WERE LOST. A SECOND COMMUNICATION WAS DUE TO A SHARED MEMORY ISSUE BETWEEN MARIO_WIN AND MARIO_RTX. AND FINALLY, A LAST COMMUNICATION FAILURE OCCURRED BECAUSE THE COOPERATIVE MODE COULD NOT BE STOPPED DUE TO A CONFLICT OF COOPERATIVE MODE STATE. HOWEVER, ITS ORIGIN CANNOT BE DETERMINED." }, { "mdr_text_key": "168457806", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING THE AUTOMATIC PORTION OF LASER REGISTRATION, WE RECEIVED THE ERROR ROBOT COULD NOT PERFORM AUTOMATIC TRAJECTORY IN ORDER TO SCAN PATIENT¿S HEAD. THIS CAUSED A 20-30-MINUTE DELAY AS THE PATIENT WAS RE-POSITIONED AND RE-REGISTERED. THEN, AT 6:40 PM, THERE WAS A ROBOT SHUT DOWN. COMMUNICATION FAILURE WITH THE ROBOT. THIS WAS DURING REGISTRATION. THIS CAUSED A 20-MINUTE DELAY AS THEY HAD TO RE-REGISTER. AT 7:40 PM, THERE WAS A ROBOT SHUT DOWN. COMMUNICATION FAILURE WITH THE ROBOT. THIS WAS AFTER REGISTRATION AND VERIFICATION, BUT BEFORE GUIDANCE AFTER DRAPING. THE ARM WAS IN THE HOME POSITION. THE ROBOT SHUT DOWN FOR NO APPARENT REASON. THIS CAUSED A 5-MINUTE DELAY. FINALLY, THERE WAS A ROBOT SHUT OFF AT 9:52 PM. COMMUNICATION FAILURE WITH THE ROBOT. THE SYSTEM WILL SHUT DOWN. WHEN TRYING TO TURN THE ROBOT BACK ON, IT DID NOT GO ON. IT WAS DISCOVERED THAT THE OUTLET WASN¿T WORKING, AND THE ROBOT TURNED BACK ON ONCE PLUGGED INTO A NEW OUTLET IN THE OR. THIS CAUSED A 5-10 MINUTE DELAY AS WE TROUBLE-SHOOTED AND GOT THE ROBOT UP AND RUNNING AGAIN." } ], "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": "" } ] }