{ "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": "3009185973-2020-00007", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200115", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190729", "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": "20200115", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "53860", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200115", "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": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20200115", "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": "20200115", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9589965", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190729", "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": "175034294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI : (B)(4). A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND THIS ANALYSIS CONCLUDED THAT THE FIRST COMMUNICATION ERROR OCCURRED DURING THE VERIFICATION STEP OF THE CONTACTLESS REGISTRATION, WHEN THE COOPERATIVE MODE WAS ACTIVATED, DUE TO AN OVER FORCE DETECTED BY THE CONTROLLER. THIS ISSUE CAN BE PROVOKED EITHER BY AN EXCESSIVE FORCE APPLIED ON THE ROBOT ARM OR ON THE TOOL OR TO A CABLE PINCH. NOT ENOUGH ELEMENTS ARE PROVIDED, IN LOG FILES AND COMPLAINT DESCRIPTION, TO DETERMINE WITH CERTAINTY WHICH WAS THE ROOT CAUSE FOR THE ISSUE. A SECOND COMMUNICATION ERROR OCCURRED IN GUIDANCE, WHEN THE ROBOT ARM WAS ON PLANNED TRAJECTORY, DUE TO A SHARED MEMORY ISSUE. (B)(4)." }, { "mdr_text_key": "175034295", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING THE VERIFICATION STEP, A COMMUNICATION ERROR OCCURRED WHILE MOVING TO ONE OF THE VERIFICATION POINTS. THE ROBOT WAS RESTARTED AND THE VERIFICATION SCREEN WAS OPENED TO RE-CHECK THE POINTS. WHILE THE POINTS LOOKED GOOD ORIGINALLY, OPEN RESTARTING THE DEVICE, THEY LOOKED FURTHER AWAY FROM THE SKIN. THE VERIFICATION STEP WAS STARTED AGAIN, BUT THE RED CIRCLE WAS MISSING. IT WAS NOTED THAT THE WRONG CT WAS USED TO CHECK THE VERIFICATION AND THAT WAS LIKELY WHY THE POINTS WERE OFF. THE ROBOT WAS RESTARTED AND VERIFICATION WAS ATTEMPTED AGAIN WITH THE CORRECT CONTRAST ON THE CT, BUT THE CIRCLE WAS MISSING AGAIN. THE ROBOT WAS RESTARTED A FINAL TIME AND REGISTRATION WAS RE-PERFORMED." } ], "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": "" } ] }