{ "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": "3009185973-2019-00400", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20191119", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20191021", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20191119", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1134511", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191119", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00209", "lot_number": "3.1.0.1276", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/13/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20191119", "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": "20200225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9339751", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191021", "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": "316945697", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ANALYSIS OF THE DATA LOGS FROM THE SUBJECT EVENT HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT NINE ATTEMPTS TO CONNECT THE ARM FAILED BECAUSE THE CONTROLLER DID NOT CONNECT TO THE PC. THE ERRORS CORRESPONDING TO THIS CASE ARE MISSING FROM THE CONTROLLER LOG. HOWEVER, AN INTERVENTION OF A STAÜBLI AGENT ON THE DEVICE THE (B)(6) 2019 PERMITTED TO DETERMINE THAT THE RSI CARD WAS DYSFUNCTIONAL. THEREFORE, IT IS ASSUMED THAT THE LOG DID NOT TRACE THE EVENT OF CONNECTION FAILURE AND THAT THE ARM DID NOT CONNECT BECAUSE THE CONTROLLER NEVER POWERED ON. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G4 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE. - H3 DEVICE EVALUATED BY MANUFACTURER. - H6 EVENT PROBLEM AND EVALUATION CODES. - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "316945698", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON CALLED THE COMPANY FIELD SERVICE ENGINEER (FSE) AND TOLD HIM, HE TRIED 5-6 TIMES TO START THE ROBOT. THE FSE TOLD THE SURGEON TO CHECK THE EMERGENCY STOPP BUTTON: THE BUTTON WAS LIGHTED. THE FSE ASKED TO PRESS AND RELEASE THE BUTTON. RESTART THE SYSTEM AND LEAVE IT OFF THE POWER FOR MINIMUM 1 MINUTE. THHE SURGEON DR. FREIMAN DID SO. DIRECTLY WHEN HE TURNED THE POWER ON, THE RED LIGHT OF THE EMERGENCY STOP BUTTON LIGHTS UP. CASE WAS CANCELLED. PATIENT WAS ALREADY IN GENERAL ANESTHESIA AND WAS PINNED IN THE MAYFIELD." }, { "mdr_text_key": "166944609", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #:(B)(4)." }, { "mdr_text_key": "166944610", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED THE COMPANY FIELD SERVICE ENGINEER (FSE) AND TOLD HIM, HE TRIED 5-6 TIMES TO START THE ROBOT. THE FSE TOLD THE SURGEON TO CHECK THE EMERGENCY STOP BUTTON: THE BUTTON WAS LIGHTED. THE FSE ASKED TO PRESS AND RELEASE THE BUTTON. RESTART THE SYSTEM AND LEAVE IT OFF THE POWER FOR MINIMUM 1 MINUTE. THE SURGEON (B)(6) DID SO. DIRECTLY WHEN HE TURNED THE POWER ON, THE RED LIGHT OF THE EMERGENCY STOP BUTTON LIGHTS UP. CASE WAS CANCELLED. PATIENT WAS ALREADY IN GENERAL ANESTHESIA AND WAS PINNED IN THE MAYFIELD." } ], "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": "02/25/2020" } ] }