{ "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": "3009185973-2019-00251", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190801", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190709", "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": "20190801", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "645065", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190801", "brand_name": "ROSA BRAIN", "generic_name": "COMPUTER-ASSITED 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 BRAIN 3.0", "catalog_number": "ROSA BRAIN", "lot_number": "3.0.0.21", "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": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/16/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20190801", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8849970", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190709", "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": "152903434", "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.  THE EVENT DELAYED THE SURGERY BY LESS THAN 30 MINUTES HOWEVER IT IS NOTED THAT 2 OTHER COMPLAINTS WERE REPORTED FOR THE SAME SURGERY, LEADING THE SURGEON TO RESUME THE SURGERY WITHOUT ROSA BRAIN DEVICE. ONLY ONE COMPLAINT WILL BE REPORTED FOR THE NON USE OF ROSA BRAIN. UDI# : (B)(4)." }, { "mdr_text_key": "152903435", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING THE FIFTH ATTEMPT TO REGISTER THE PATIENT, AN UNEXPECTED ROBOT SHUTDOWN OCCURRED. NO ERROR WAS SHOW ON SCREEN, SCREEN WENT BLACK, WHILE THE LASER STAYED ON. THE SYSTEM REMAINED PLUGGED IN, NO CONTACT HAD BEEN MADE WITH THE ROSA POWER CORD OR POWER OUTLET. A BRAINLAB SYSTEM WAS PLUGGED INTO SAME OUTLET AND WAS NOT AFFECTED. AT THIS POINT, THE USE OF ROSA FOR THE CASE WAS ABORTED BECAUSE OF LAST REGISTRATION ISSUE. SEEG WITH GRIDS AND STRIPS PROCEDURE. NO INCISION MADE." }, { "mdr_text_key": "316691937", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AN UNEXPECTED ROBOT SHUTDOWN OCCURRED DURING A SURGERY. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION INDICATED THAT THE CONTROLLER DETECTS A UDP SOCKET TIMEOUT WHICH IS ASSUMED TO BE A CONSEQUENCE OF THE PC CRASH. NO MORE EVIDENCE ARE PROVIDED TO CONCLUDE ABOUT THE CAUSE FOR THIS ISSUE. THE CRASH MIGHT BE PROVOKED BY THE MULTIPLE ATTEMPTS TO PERFORM THE LASER REGISTRATION. THIS MIGHT CAUSE AN ISSUE IN THE MEMORY MANAGEMENT." }, { "mdr_text_key": "316691938", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE FIFTH ATTEMPT TO REGISTER THE PATIENT, AN UNEXPECTED ROBOT SHUTDOWN OCCURRED. NO ERROR WAS SHOW ON SCREEN, SCREEN WENT BLACK, WHILE THE LASER STAYED ON. THE SYSTEM REMAINED PLUGGED IN, NO CONTACT HAD BEEN MADE WITH THE ROSA POWER CORD OR POWER OUTLET. A BRAINLAB SYSTEM WAS PLUGGED INTO SAME OUTLET AND WAS NOT AFFECTED. AT THIS POINT, THE USE OF ROSA FOR THE CASE WAS ABORTED BECAUSE OF LAST REGISTRATION ISSUE. SEEG WITH GRIDS AND STRIPS PROCEDURE. NO INCISION MADE." } ], "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": "01/08/2020" } ] }