{ "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": "3009185973-2021-00080", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210319", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "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": "20210319", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "422149", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20210319", "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": "", "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", "Application Program Freezes or Fails to Launch", "Connection Problem", "Application Program Freezes or Fails to Launch" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20210319", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210319", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11527609", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210301", "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": "242166529", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UNIQUE IDENTIFIER (UDI) #: (B)(4). A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND PERMITTED TO CONCLUDE THAT THE EVENTS REPORTED ARE DUE TO KNOWN ISSUES. THE FREEZE WAS DUE TO THE OVERLAPPING OF TWO COMMANDS, A COOPERATIVE SLOW MODE AND AN AUTOMATIC MOVEMENT. THEN THE ARM CONNECTION FAILED DUE TO A MEMORY ALLOCATION ISSUE THAT PREVENTS ITS COMPLETE INITIALIZATION. CONSEQUENTLY, THE SOFTWARE ASKED TO RESTART THE APPLICATION OR SHUT DOWN THE COMPUTER. IN ORDER TO SOLVE THE ISSUE, THE USER HAD TO SHUT DOWN AND REBOOT THE COMPUTER. THESE SOFTWARE ANOMALIES WILL BE ADDRESSED THROUGH OUR DESIGN ISSUES MANAGEMENT PROCESS." }, { "mdr_text_key": "242166530", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE COMPANY REPRESENTATIVE WAS PRESENT FOR A BRAIN SURGERY CASE. AFTER GETTING THE MEASUREMENT, THE SURGEON WANTED TO BACK OUT IN AXIAL FAST. HE STARTED PEDALING THE VIGILANCE DEVICE BUT BEHIND THE PEDAL SCREEN, THERE WAS AN ERROR SAYING THAT THE ROBOT WAS IN A SINGULAR POSITION. WHEN IT GOT BACK TO THE INTERMEDIATE POSITION, THE SCREEN FROZE AT 1:12 PM. THEN THE COMPANY REPRESENTATIVE DID A HARD SHUTDOWN FROM THE MAIN POWER SWITCH AT THE BOTTOM OF THE ROBOT (THE SHUTDOWN/RESTARTS OCCURRED AT 1:17 PM/1:18 PM). THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AND IT WOULD NOT CONNECT SO WE DID A MANUAL RELEASE OF EACH PART OF THE ARM. THE COMPANY REPRESENTATIVE RESTARTED THE ROBOT AGAIN (ONLY OFF FOR 30 SEC.) AND IT WOULD NOT CONNECT. THEN, THE COMPANY REPRESENTATIVE HAD THE ROBOT UNPLUGGED FOR ABOUT 5-10 MINUTES, AND WE GOT IT TO CONNECT AND WERE ABLE TO CONTINUE ON WITH THE CASE. SURGERY DELAY WAS ABOUT 20-30 MINUTES FOR THIS COMPLAINT EVENT. THE ANESTHESIOLOGIST SAID SOME ADDITIONAL ANESTHESIA WAS GIVEN TO KEEP THE PATIENT 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": "" } ] }