{ "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": "3009185973-2019-00126", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190410", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190320", "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": "20190410", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "293582", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190410", "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", "Computer Software Problem" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20190410", "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": "20190409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8498865", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190320", "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": "141435301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). IT WAS REPORTED THAT DURING A SURGERY, TWO SOFTWARE CRASHES AND REGISTRATION ISSUES OCCURRED. 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 FIRST CRASH CANNOT BE DETERMINED AND THE ROOT CAUSE OF THE SECOND CRASH CANNOT BE DETERMINED TOO. THE TECHNICAL ROOT CAUSE OF THE REGISTRATION ISSUES IS A USE ERROR WHO DID NOT CORRECT ROBOT POINTS WHEN HE CORRECTED REFERENCE POINTS MARKED ON IMAGES." }, { "mdr_text_key": "141435302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON WANTED TO PERFORM LASER REGISTRATION. HOWEVER, AFTER TAKING THE INITIAL POINTS AND SCANS, THE FIELD SERVICE ENGINEER (FSE) RECEIVED THE ERROR MESSAGE THAT THE \"REGISTRATION COULD NOT BE COMPUTED\". EVEN AFTER ADJUSTING THE INITIAL POINTS, FSE RECEIVED THE SAME MESSAGE. FSE AND SURGEON ATTEMPTED LASER REGISTRATION A 2ND TIME AFTER ADJUSTING THE 3D RECONSTRUCTION. UNFORTUNATELY, THE SAME ERROR MESSAGE WAS RECEIVED AFTER TAKING THE INITIAL POINTS AND SCANS AGAIN. FSE MOVED THE ROBOT CLOSER TO THE PATIENT, AND AFTER THE 3RD REGISTRATION ATTEMPT, REGISTRATION WAS COMPLETED SUCCESSFULLY. PATIENT WAS UNDER ANESTHESIA, NO INCISION HAD BEEN MADE. DELAY TO CASE WAS SUPERIOR TO 30 MINUTES. NO PATIENT IMPACT. ADDITIONALLY, 2 ROBOT SHUT DOWNS OCCURRED DURING THE CASE. THE FIRST SHUTDOWN OCCURRED DURING THE 1ST REGISTRATION ATTEMPT. THE SECOND SHUTDOWN OCCURRED DURING THE 3RD REGISTRATION ATTEMPT." } ], "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": "" } ] }