{ "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": "*", "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": "3009185973-2018-00128", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20180419", "manufacturer_address_2": "", "pma_pmn_number": "PK151359", "date_of_event": "20180411", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH 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": "20180419", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "287592", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20180419", "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 BAIN SOFTWARE", "catalog_number": "N/A", "lot_number": "3.0.0.20", "other_id_number": "N/A", "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": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/24/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20180419", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20180524", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7442555", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180413", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Inspection" ], "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": "105887301", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. SURGEON STATED THE HEMORRHAGE WAS SMALL IN NATURE AND THAT NO FURTHER ACTION WOULD NEED TO BE TAKEN ON IT. BOTH ABLATIONS WERE SUCCESSFUL AND ACCURATE." }, { "mdr_text_key": "105887302", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CASE WAS PLACING TWO MONTERIS LASER FIBERS FOR ABLATION FOLLOWING AN SEEG CASE FOR THE PATIENT. AFTER THE FIRST FIBER WAS PLACED, IT WAS NOTED ON THE MRI THAT THERE WAS A HEMORRHAGE. THIS WAS NOT IN FACT DUE TO THE LASER FIBER, BUT ACTUALLY DUE TO THE PREVIOUS SEEG CASE, TWO DAYS BEFORE. SURGEON HAD NOT SEEN IT UNTIL THIS POINT. IT WAS NOTED THAT IT WAS EITHER RELATED TO TRAJECTORY 'LPC 2' OR 'RC', MORE LIKELY LPC 2. THE ELECTRODES WERE VERY ACCURATE FROM THE CASE. SURGEON STATED THAT HE DID NOT BELIEVE ANY FAULT SHOULD BE ATTRIBUTED TO ROSA." }, { "mdr_text_key": "276204463", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "TECHNICAL INVESTIGATION CONCLUDED THAT NEITHER DURING THE LASER FIBER ABLATION OR THE SEEG THE DEVICE HAD A FAILURE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SURGEON CONFIRMED THAT ROSA DEVICE WAS NOT RESPONSIBLE FOR THE HEMORRHAGE. IT IS CONCLUDED THAT THE HEMORRHAGE WAS DUE TO PATIENT ANATOMY OR ANOTHER EXTERNAL FACTOR. CORRECTED DATA: DATE OF THIS REPORT, ADDITIONAL DEVICE INFORMATION, DATE RECEIVED BY MANUFACTURER , IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE." } ], "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": "05/24/2018" } ] }