{ "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": "3009185973-2019-00372", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20191024", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190925", "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": "20191024", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1029021", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191024", "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": "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": "20250811", "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": "20191024", "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": "20191024", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9233476", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190925", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "173062118", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. IT WAS NOTED THAT PREVIOUS COMPLAINTS WERE RECEIVED FOR THE SAME DEVICE DUE TO THE SAME CAUSES. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THE FIRST COMMUNICATION ERROR OCCURRED DURING THE CLEARANCE PROCEDURE DUE TO A VIGILANCE DEVICE FAILURE. THIS ISSUE CAN BE PROVOKED BY A MOMENTARY BREAKDOWN OR MIS-CONNECTION OR AN INCORRECT USAGE OF THE FOOT PEDAL. HOWEVER, NOT ENOUGH ELEMENTS ARE PROVIDED TO CONCLUDE ABOUT THE ROOT CAUSE FOR THE ISSUE. THE SECOND COMMUNICATION ERROR OCCURRED IN GUIDANCE, WHEN THE ROBOT ARM WAS ON PLANNED TRAJECTORY AND THE COOPERATIVE MODE WAS ACTIVATED IN AXIAL MODE AND IN FAST SPEED, DUE TO THE ROBOT ARM POSITION. THIS IS A KNOWN ANOMALY. THE THIRD ISSUE WAS DETECTED AT THE ARM CONNECTION AND AFTER A ROBOT ARM / MAYFIELD HEAD HOLDER COLLISION (INVESTIGATED IN A DIFFERENT COMPLAINT). THE ARM WAS LIKELY STILL IN CONTACT WITH THE MAYFIELD HEAD HOLDER AND THE CONTROLLER DETECTED A DEFAULT SITUATION ON THE SAME AXIS INVOLVED IN COLLISION AND PROVOKED THE COMMUNICATION ERROR AND THE DEVICE SHUTDOWN. THIS EVENT CAUSED THE DEVICE SHUTDOWN WHICH IS A NORMAL BEHAVIOR. ACCORDING TO THE COMPLAINT DESCRIPTION, THE LAST ISSUE OCCURRED AFTER THE SURGERY, WHEN THE ROBOT ARM WAS DRIVEN BACK TO HOME. SEVERAL VIGILANCE DEVICE FAILURES WERE DETECTED WHEN THE RESIDENT / MED STUDENT WAS STEPPING ON AND OFF THE PEDAL, CONSEQUENTLY, THESE ISSUES WERE MOST LIKELY DUE TO AN INCORRECT USAGE OF THE FOOT PEDAL. THEN, THE DEVICE SHUT DOWN DUE TO A CONFLICT OF THE COOPERATIVE MODE STATE, HOWEVER, NOT ENOUGH ELEMENTS ARE PROVIDED TO EXPLAIN THE ORIGIN OF THIS CONFLICT. (B)(4)." }, { "mdr_text_key": "173062119", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE COMPANY FIELD SERVICE ENGINEER WAS PRESENT FOR A SEEG CASE. THE FIRST COMPLAINT OCCURRED IN THE MORNING CASE AT 9:18 AM WHEN THE ROBOT SHUT DOWN IN FREE AND FAST WHILE BACKING OUT AFTER REGISTRATION WAS COMPLETE. THE SECOND COMPLAINT OCCURRED IN THE MORNING CASE AT 10:14 AM WHEN THE ROBOT SHUT DOWN IN AXIAL FAST WHILE IN GUIDANCE MODE. THERE WAS A VIGILANCE DEVICE FAILURE AND THE ROBOT SHUT DOWN. THE ROBOT ARM WAS COMING BACK TO HOME AFTER THE SURGERY AND THE RESIDENT/MED STUDENT WAS STEPPING ON AND OFF THE PEDAL WHEN THE VIGILANCE DEVICE FAILED AND SHUT DOWN." } ], "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": "" } ] }