{ "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": "3009185973-2019-00185", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190522", "manufacturer_address_2": "", "pma_pmn_number": "K151359", "date_of_event": "20190425", "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": "20190522", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "427412", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190522", "brand_name": "ROSA BRAIN", "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 BRAIN", "catalog_number": "N/A", "lot_number": "3.0.0.21", "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": [ "Computer Software Problem", "Connection Problem", "Computer Software Problem", "Connection Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20190522", "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": "20190522", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8631222", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190425", "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": "145750105", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). IT WAS REPORTED THAT FIRST THE ROBOT WOULD NOT CONNECT. THEN, THE LASER REGISTRATION FAILED THREE TIMES AND WHILE PERFORMING THE FOURTH REGISTRATION, A SHUTDOWN OCCURRED AND THE SURGERY WAS ABORTED. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION, THE TECHNICAL ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE A KNOWN DESIGN DEFECT BR-139. REQUIREMENT TO ESCALATE THIS DESIGN DEFECT IS PERFORMED AS PART OF THE DESIGN DEFECT MANAGEMENT PROCESS. THE TECHNICAL ROOT CAUSE OF THE FAILED LASER REGISTRATION IS A USE ERROR, IFU WAS NOT FOLLOWED. THE TECHNICAL ROOT CAUSE OF THE SHUTDOWN IS A CRASH OF THE OPERATING SYSTEM. NO MORE EVIDENCES ARE PROVIDED TO CONCLUDE ABOUT THE ROOT CAUSE FOR THIS ISSUE." }, { "mdr_text_key": "145750106", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING AN ASSISTED SURGERY, CONTACTLESS REGISTRATION WAS SELECTED, BUT THE FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE INITIAL SCREEN SAYING TO 'PLEASE WAIT' WAS TAKING A LOT LONGER THAN USUAL (TRYING TO CONNECT TO CONTROLLER). AFTER WAITING A MINUTE, THE MESSAGE 'FAILURE CONNECTING TO THE ROBOT' WAS SHOWN, AND THEN A WINDOWS MESSAGE APPEARED SAYING THE 'ACCESSIBILITY ON-SCREEN KEYBOARD IS NOT RESPONDING'. THE FSE BACKED OUT OF THE SOFTWARE, AND SHUT THE ROBOT DOWN AS NORMALLY DONE. AFTER WAITING A FEW MINUTES, THE ROBOT WAS RESTARTED AND THIS TIME THERE WAS A SUCCESSFUL CONNECTION TO THE CONTROLLER, AND THE LASER REGISTRATION COULD BE STARTED. AFTER PERFORMING THE LASER REGISTRATION, THE VERIFICATION WAS PERFORMED. THE VERIFICATION FOR NASION, BONY TIP OF THE NOSE, OUTER CANTHI, AND FOREHEAD WERE ACCEPTABLE. SOME AREAS OF THE TEMPLES WERE ALSO ACCEPTABLE, BUT THERE WERE SOME AREAS THAT WERE SHOWING THE LASER BEING OFF THE SKIN ABOUT 3-4MM. AFTER SEEING THIS, THE SURGEON AND FSE DECIDED THIS WAS NOT AN ACCEPTABLE REGISTRATION TO USE. A SECOND REGISTRATION WAS PERFORMED, BUT SIMILAR RESULTS WERE OBTAINED. A CHANGE TO THE 3D MODEL CALCULATION WAS PERFORMED TO SEE IF THAT SOLVED THE ISSUE. THE PIN THAT WAS CAUSING THE SKIN TO BE PUSHED UP ON THE FOREHEAD WAS CHANGED SO THAT THE SKIN WASN'T BEING PULLED AS MUCH. A THIRD REGISTRATION WAS PERFORMED, AND THE RESULTS WERE SIMILAR - AREAS AROUND THE TEMPLES WERE SHOWING MULTIPLE MM'S OFF AND OTHER PARTS OF THE FACE BEING ACCEPTABLE FOR THE VERIFICATION. A FOURTH AND FINAL LASER REGISTRATION WAS BEING PERFORMED BEFORE THE SOFTWARE RANDOMLY RESTARTED DURING THE PROCESS. AFTER WAITING A MINUTE, THE MAIN SCREEN POPPED BACK. THE ROBOT WAS NOT RESTARTED, SO ONCE THE GREEN SCREEN APPEARED, IT SEEMED LIKE THE SOFTWARE RESTARTED ITSELF WITHOUT THE ROBOT BEING TURNED OFF. WHEN THE REGISTRATION WAS LOST DUE TO THE GREEN SCREEN, THE SURGEON DECIDED THAT THEY DID NOT FEEL COMFORTABLE WITH PROCEEDING, SO THE CASE WAS CANCELLED. THE FSE PERFORMED THE PREVENTIVE MAINTENANCE AFTER THE CASE WAS CANCELLED. THE CST PERFORMED THE PM AND ALL OF THE TESTS PASSED. THE ROBOT SEEMED TO BE WORKING CORRECTLY. THE LASER USED FOR THE ACCURACY TEST AND APPLICATIVE TEST WORKED WELL, AND NO OTHER ISSUES WERE EXPERIENCED." } ], "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": "" } ] }