{ "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": "3009185973-2020-00201", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200903", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20200817", "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": "20200903", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "953406", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200903", "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": "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": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/20/2020", "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": "20200903", "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": "20201023", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10489130", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200817", "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": "321186580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND LED TO THE FOLLOWING OBSERVATIONS : UPON EACH RESTART, THE CONTROLLER DID NOT POWER ON PROPERLY. AS A RESULT, THE ROSA SOFTWARE COULD NOT CONNECT TO THE CONTROLLER AND DISPLAYED AN ERROR MESSAGE. THE MAIN ASSUMPTION IS THAT THIS PROBLEM WAS DUE TO A TRANSIENT ELECTRICAL ISSUE, BECAUSE THE PROBLEM WAS SOLVED AFTER THE USER TURNED THE CONTROLLER SWITCH TO THE OFF POSITION, UNPLUGGED THE POWER CORD FROM THE WALL, AND RESTARTED THE ROBOT. HOWEVER, THIS HYPOTHESIS COULD NOT BE CONFIRMED. THERE WAS NO IMPACT FOR THE PATIENT OTHER THAN THE REPORTED DELAY." }, { "mdr_text_key": "321186581", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING SURGERY, THE ROSA SOFTWARE SHUTDOWN. UPON RESTART, THE CONTROLLER WOULD NOT CONNECT. THE SURGEON, NOTIFIED THE CLINICAL REPRESENTATIVE. THE SITE WAS INSTRUCTED TO POWER OFF THE ROBOT PC, SWITCH THE CONTROLLER SWITCH TO THE OFF POSITION, AND UNPLUG THE POWER CORD FROM THE WALL FOR 30 SECONDS. UPON RESTART, THE CONTROLLER DID CONNECT AND THE CASE COULD CONTINUE. THIS INCIDENT DID CAUSE A DELAY IN OF ABOUT 30 MINUTES TO THE SURGERY WHILE THE PATIENT WAS ALREADY IN THE ROOM AND ASLEEP." }, { "mdr_text_key": "205878417", "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. UDI#: (B)(4)." }, { "mdr_text_key": "205878418", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING SURGERY, THE ROSA SOFTWARE SHUTDOWN. UPON RESTART, THE CONTROLLER WOULD NOT CONNECT. THE SURGEON, NOTIFIED THE CLINICAL REPRESENTATIVE. THE SITE WAS INSTRUCTED TO POWER OFF THE ROBOT PC, SWITCH THE CONTROLLER SWITCH TO THE OFF POSITION, AND UNPLUG THE POWER CORD FROM THE WALL FOR 30 SECONDS. UPON RESTART, THE CONTROLLER DID CONNECT AND THE CASE COULD CONTINUE. THIS INCIDENT DID CAUSE A DELAY IN OF ABOUT 30 MINUTES TO THE SURGERY WHILE THE PATIENT WAS ALREADY IN THE ROOM AND ASLEEP." } ], "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": "10/26/2020" } ] }