{ "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": "3009185973-2018-00271", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181015", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181002", "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": "20181015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "805079", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181015", "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": "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": [ "Insufficient Device Problem Information", "Appropriate Device Problem Term/Code Not Available", "Insufficient Device Problem Information", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/17/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20181015", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage, Cerebral", "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20190204", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7964553", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181004", "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": "123671664", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "123671665", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS CALLED ON THURSDAY (B)(6) 2018 BY THE HEAD NEURO NURSE TO INFORM ME THAT THE PATIENT FROM TUESDAY¿S ((B)(6) 2018) SEEG CASE HAD EXPERIENCED A BLEED AND THAT ALL OF THE ELECTRODES HAD BEEN TAKEN OUT. THIS CASE WAS COVERED BY AN FSE, BUT HAD BEEN A SMOOTH CASE WITH NO ISSUES WITH THE DEVICE. THE SURGEON INFORMED THAT HE NOTICED THAT THERE WAS MORE BLEEDING THAN NORMAL WHEN THE ANCHOR BOLT WAS PLACED FOR TRAJECTORY 7, BUT THEY HAD USED ¿FLOSEAL¿ TO STOP THE BLEEDING AND WAITED ABOUT 10 MINUTES BEFORE PUTTING THE ELECTRODE THROUGH THE BOLT. THEY THEN FINISHED UP THE CASE (6 MORE TRAJECTORIES), BUT ANESTHESIST STARTED TO NOTICE CHANGES IN THE PATIENT¿S VITAL SIGNS. THE PATIENT WAS DETACHED FROM ROSA AND BROUGHT DOWN TO GET A CT SCAN WHILE STILL ASLEEP. THE SCAN SHOWED A SUPERFICIAL BLEED AND THE PATIENT WAS AUTOMATICALLY BROUGHT BACK TO THE OR TO ADDRESS THE PROBLEM. AT THIS TIME ALL OF THE ELECTRODES WERE REMOVED AND THE BLEED WAS CLEARED. THE PATIENT IS NOW 2 DAYS POST-OPERATIVE AND THE SURGEON SAID THAT THE PATIENT IS MAKING DRASTIC IMPROVEMENTS,BUT IS NOT BACK TO BASELINE YET. THE SURGEON SAID THAT HE HAD NOT MERGED THE POST-OP CT TO THE ROSA PLANNING, BUT LOOKING BACK AT THE PLAN, THERE WAS A CORTICAL VESSEL WITHIN 2-3MM OF THE PLANNED ENTRY POINT. WHILE REVIEWING THE POST-OP SCAN WITH THE SURGEON, THERE WAS ABOUT A 2.5MM SHIFT IN THE ENTRY POINT OF THE BOLT, BUT UPON REVIEWING THE PLAN AND POST-OP WITH AN ADDITIONAL SURGEON, IT WAS AGREED THAT THE TRAJECTORY WAS PLANNED TOO CLOSE TO A SURFACE VESSEL." }, { "mdr_text_key": "312101666", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS CALLED ON THURSDAY (B)(6) 2018 BY THE HEAD NEURO NURSE TO INFORM ME THAT THE PATIENT FROM TUESDAY¿S (B)(6) 2018) SEEG CASE HAD EXPERIENCED A BLEED AND THAT ALL OF THE ELECTRODES HAD BEEN TAKEN OUT. THIS CASE WAS COVERED BY AN FSE, BUT HAD BEEN A SMOOTH CASE WITH NO ISSUES WITH THE DEVICE. THE SURGEON INFORMED THAT HE NOTICED THAT THERE WAS MORE BLEEDING THAN NORMAL WHEN THE ANCHOR BOLT WAS PLACED FOR TRAJECTORY 7, BUT THEY HAD USED FLOSEAL TO STOP THE BLEEDING AND WAITED ABOUT 10 MINUTES BEFORE PUTTING THE ELECTRODE THROUGH THE BOLT. THEY THEN FINISHED UP THE CASE (6 MORE TRAJECTORIES), BUT ANESTHESIST STARTED TO NOTICE CHANGES IN THE PATIENT¿S VITAL SIGNS. THE PATIENT WAS DETACHED FROM ROSA AND BROUGHT DOWN TO GET A CT SCAN WHILE STILL ASLEEP. THE SCAN SHOWED A SUPERFICIAL BLEED AND THE PATIENT WAS AUTOMATICALLY BROUGHT BACK TO THE OR TO ADDRESS THE PROBLEM. AT THIS TIME ALL OF THE ELECTRODES WERE REMOVED AND THE BLEED WAS CLEARED. THE PATIENT IS NOW 2 DAYS POSTOPERATIVE AND THE SURGEON SAID THAT THE PATIENT IS MAKING DRASTIC IMPROVEMENTS,BUT IS NOT BACK TO BASELINE YET. THE SURGEON SAID THAT HE HAD NOT MERGED THE POST-OP CT TO THE ROSA PLANNING, BUT LOOKING BACK AT THE PLAN, THERE WAS A CORTICAL VESSEL WITHIN 2-3MM OF THE PLANNED ENTRY POINT. WHILE REVIEWING THE POST-OP SCAN WITH THE SURGEON, THERE WAS ABOUT A 2.5MM SHIFT IN THE ENTRY POINT OF THE BOLT, BUT UPON REVIEWING THE PLAN AND POST-OP WITH AN ADDITIONAL SURGEON, IT WAS AGREED THAT THE TRAJECTORY WAS PLANNED TOO CLOSE TO A SURFACE VESSEL." }, { "mdr_text_key": "312101667", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AN HEMORRHAGE WAS NOTED POST-OPERATIVELY. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF DATA LOGS AND A TEST AT MANUFACTURING SITE WERE PERFORMED AND DETERMINED THAT THE CAUSE OF THE HEMORRHAGE MOST PROBABLY RESULTS FROM A TRAJECTORY THAT WAS PLANNED TOO CLOSE TO A SURFACE VESSEL, POSSIBLY RESULTING FROM AN INACCURACY SUPERIOR TO 2 MM AT THE ENTRY POINT FOR 14 OF THE 15 TRAJECTORIES. THE MOST PROBABLE ROOT CAUSE OF THE INACCURACY IS AN INELASTIC HEAD MOVEMENT. THE DEVICE WAS TESTED ON 05 OCT 2018 DURING PREVENTIVE MAINTENANCE AND ALL TEST PASSED. THE ANALYSIS OF THE EVENT DID NOT REVEAL ANY DEVICE FAILURE. THE DEVICE OPERATED AS SPECIFIED, AND DID NOT CONTRIBUTE TO THE EVENT. (B)(4)." } ], "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": "02/04/2019" } ] }