{ "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": "3009185973-2019-00380", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20191107", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191018", "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": "20191107", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1086699", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191107", "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": "ROSAS00303", "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": "20250804", "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": "20191107", "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": "20191107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9289202", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191018", "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": "165442158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THIS ANALYSIS CONCLUDED THAT THE FIRST COMMUNICATION ERROR WAS DUE TO THE FORCE APPLIED ON THE ROBOT ARM. THIS LAST WAS POSITIONED AT AN EXTREME RANGE AND WAS MORE SENSITIVE CONSEQUENTLY, THE FORCE APPLIED ON IT WAS CONSIDERED AS TOO EXCESSIVE BY THE CONTROLLER. THEREFORE, THE SHUTDOWN IS A NORMAL BEHAVIOR OF THE DEVICE. THEN, A SECOND SHUTDOWN OCCURRED DURING AN AUTOMATIC MOVE, WHEN THE ROBOT ARM WAS DRIVEN ONTO A PLANNED TRAJECTORY, DUE TO A SHARED MEMORY ISSUE. (B)(4)." }, { "mdr_text_key": "165442159", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE COMPANY FIELD SERVICE ENGINEER WAS PRESENT FOR A SEEG CASE WITH SURGEONS. DURING THE CASE, THE ROBOT SHUT DOWN TWICE DUE TO THE ARM BEING FULLY EXTENDED. THE FIRST TIME IT HAPPENED WAS AT 3:23 PM DURING REGISTRATION. BEFORE SHUTTING DOWN WE SAW AN ERROR 'IMPOSSIBLE TO RECORD POINT' WITH THE DISTANCE SENSOR AS THE TOOL ON THE ROBOT ARM. THIS CAUSED A 20 TO 30-MINUTE DELAY AS WE NEEDED TO START REGISTRATION AGAIN. THE SECOND TIME THE ROBOT SHUT DOWN DUE TO THE ARM BEING FULLY EXTENDED WAS DURING THE GUIDANCE PORTION OF THE SURGERY WHEN WE WERE GOING TO A TRAJECTORY ON THE PATIENT¿S RIGHT SIDE. THIS OCCURRED AT 5:57 PM. THERE WAS AN ERROR 'COMMUNICATION FAILURE WITH THE ROBOT.' THIS CAUSED A 5-10 MINUTE DELAY." } ], "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": "" } ] }