{ "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": "3009185973-2020-00213", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200915", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20200901", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200915", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "998972", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200915", "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": "0", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.4.1650", "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": [ "Connection Problem", "Connection Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/05/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20200915", "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": "20201106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10533810", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200901", "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": "207018979", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "207018980", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO BOOT UP ROBOT PRIOR TO SURGERY. ROBOT PC WOULD NOT TURN ON, BUT CONTROLLER STARTED AS EXPECTED. THE FSE OPENED ROBOT AND CONFIRMED THAT ALL CONNECTIONS WERE CONNECTED PROPERLY, AND THAT ALL FUSES APPEARED TO BE INTACT. THE FSE ATTEMPTED TO RE-SEAT MEMORY, MOTHERBOARD, AND CONNECTIONS, BUT WITHOUT CORRECTING THE ISSUE." }, { "mdr_text_key": "321102873", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO BOOT UP ROBOT PRIOR TO SURGERY. ROBOT PC WOULD NOT TURN ON, BUT CONTROLLER STARTED AS EXPECTED. THE FSE OPENED ROBOT AND CONFIRMED THAT ALL CONNECTIONS WERE CONNECTED PROPERLY, AND THAT ALL FUSES APPEARED TO BE INTACT. THE FSE ATTEMPTED TO RE-SEAT MEMORY, MOTHERBOARD, AND CONNECTIONS, BUT WITHOUT CORRECTING THE ISSUE." }, { "mdr_text_key": "321102874", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REPORTEDLY, DURING PRE-OPERATIVE INSPECTION ON 29-JUN-2020, THE FIELD SERVICE ENGINEER (FSE) HAD TROUBLE TURNING ON THE ROBOT PC OF THE SUBJECT DEVICE (REFER TO (B)(4)). AFTER SOME TROUBLESHOOTING, THE FSE PUSHED THE RESET BUTTON, SOLVING THIS ISSUE. THE PC TURNED ON, AND NO FURTHER ISSUE OCCURRED DURING THE REST OF THE SURGERY. ON (B)(6) 2020, IT WAS IMPOSSIBLE TO START THE ROBOT PC (SUBJECT COMPLAINT (B)(4)) EVEN AFTER SOME TROUBLESHOOTING WAS PERFORMED BY THE FSE (TURN ON THE DEVICE WITH THE MAIN BUTTON, CHECK THE WIRES OF THE PC, CHECK THE FUSES OF THE DEVICE, CHECK OF THE MEMORY CHIPS, THE MOTHERBOARD AND THE CONNECTIONS). ALTHOUGH THE CONTROLLER COULD BE STARTED, NONE OF THE MANIPULATIONS ATTEMPTED BY THE FSE PERMITTED TO TURN ON THE ROBOT PC. IT WAS THEN DECIDED TO REPLACE THE ROBOT PC, AND THE REPLACEMENT TOOK PLACE ON (B)(6) 2020. THE ROOT CAUSE OF THE MALFUNCTION OF THE DEVICE PC CANNOT BE DETERMINED AS IT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THE PC HAD BEEN USED FOR 4 YEARS AND 1 MONTH BEFORE THE FAILURE OCCURRED. THE EVENT DESCRIBED IN THE COMPLAINT IS CONFIRMED." } ], "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": "11/06/2020" } ] }