{ "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": "*", "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": "3009185973-2018-00064", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180307", "manufacturer_address_2": "", "pma_pmn_number": "PK101791", "date_of_event": "20180302", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH 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": "20180307", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "163080", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180307", "brand_name": "ROSA SURGICAL DEVICE", "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", "catalog_number": "N/A", "lot_number": "ROSA 2.5.8.4", "other_id_number": "N/A", "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": [ "Device Displays Incorrect Message", "Device Displays Incorrect Message" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/12/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20180307", "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": "20180612", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7319696", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180302", "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": "101689339", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE (B)(4) HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. NO CODE AVAILABLE' WAS SELECTED AS PATIENT CODE AS THE SURGERY HAS BEEN ABORTED, ACCORDING TO OUR INTERNAL GUIDELINE IT IS CONSIDERED AS A SERIOUS INJURY." }, { "mdr_text_key": "101689340", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT WHEN STARTING THE CONTACTLESS REGISTRATION, AT INITIALIZATION OF THE SYSTEM, A MESSAGE APPEARED \"IMPOSSIBLE TO CONNECT WITH ROBOT ARM\". AFTER FEW TRIES, THEY DECIDED TO CANCEL THE SURGERY USING THE DEVICE AND DEVICE WAS PUT OUT OF THE OR. A FIELD SERVICE ENGINEER THAT WAS PRESENT WAS INFORMED BY THE MEDICAL TEAM THAT THE ROSA DEVICE IS NOT PLUG ON A SECURITY WALL OUTLET DURING SURGERIES." }, { "mdr_text_key": "296010574", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DHR AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THE DATA LOG ANALYSIS PERFORMED INDICATES THE FORCES THREAD FAILED TO START INDICATING THAT THE ROBOT COULD NOT CONNECT TO THE FORCE SENSOR. HOWEVER THE ROOT CAUSE FOR THIS ERROR CANNOT BE DETERMINED. THE CST WAS PRESENT AT THE TIME OF THE EVENT AND SOLVED THE ISSUE AFTER THE SURGERY WAS ABORTED. THE DEVICE IS STILL USED AT THE COSTUMER LOCATION. A REVIEW OF PREVENTATIVE MAINTENANCE SHOWS THAT NO ANOMALIES WERE PRESENT AND THE DEVICE FUNCTIONED AS INTENDED. THE WIRE CONNECTIONS WERE CHECKED AND FOUND NO ISSUE." } ], "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": "06/13/2018" } ] }