{ "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": "3009185973-2020-00061", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200218", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200122", "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": "FR", "manufacturer_contact_area_code": "", "date_added": "20200218", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "185270", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200218", "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 3.1", "catalog_number": "ROSAS00201", "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": "03/12/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20200218", "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": "20200317", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9719154", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200122", "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": "317939142", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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. ACCORDING TO THE COMPLAINT DESCRIPTION, CONNECTION OF THE CONTROLLER TO ROSA SOFTWARE FAILED DUE TO THE BAD CONNECTION OR DISCONNECTION OF THE STARC CARD. AS MENTIONED BY THE REPORTER, THE ISSUE WAS SOLVED ON NEXT EVENT'S DAY BY THE FSE BY RECONNECTING THE STARC CARD TO THE CONTROLLER. THE ROOT CAUSE OF THE STARC CARD CONNECTION ISSUE CANNOT BE DETERMINED. NO NEW EVENT RELATED TO THE STARC CARD OCCURRED SINCE THIS EVENT." }, { "mdr_text_key": "317939143", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER RECEIVED A CALL FROM THE SURGEON BECAUSE THE CONTROLLER OF THE ROBOT (B)(6) HAS NOT ACHIEVED TO ESTABLISHED A CONNECTION WITH ROSA SOFTWARE 3.1.0. AFTER SOME TROUBLESHOOTING'S BY PHONE, THOMAS CONCLUDED THAT THE ISSUE CANNOT BE SOLVED WITHOUT ANY TECHNICAL ASSISTANCE ON SITE. THE SURGERY WAS CANCELED, WITH NO PATIENT IMPACT. THE NEXT DAY, ANOTHER FSE AN WAS ON SITE. HE NOTICED THAT THE STARC CARD WAS LOOSING. HE SOLVED THE ISSUE BY RECONNECTING THE STARC CARD TO THE CONTROLLER." }, { "mdr_text_key": "189882140", "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. (B)(4)." }, { "mdr_text_key": "189882141", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) RECEIVED A CALL FROM THE SURGEON BECAUSE THE CONTROLLER OF THE ROBOT BS18026 HAS NOT ACHIEVED TO ESTABLISHED A CONNECTION WITH ROSA SOFTWARE (B)(4). AFTER SOME TROUBLESHOOTINGS BY PHONE, THOMAS CONCLUDED THAT THE ISSUE CANNOT BE SOLVED WITHOUT ANY TECHNICAL ASSISTANCE ON SITE. THE SURGERY WAS CANCELED, WITH NO PATIENT IMPACT. THE NEXT DAY, ANOTHER FSE AN WAS ON SITE. HE NOTICED THAT THE STARC CARD WAS LOOSING. HE SOLVED THE ISSUE BY RE-CONNECTING THE STARC CARD TO THE CONTROLLER." } ], "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": "03/18/2020" } ] }