{ "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": "3009185973-2019-00034", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190214", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190122", "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": "20190214", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "133047", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190214", "brand_name": "ROSA BRAIN", "generic_name": "COMPUTER-ASSISTED SURGCAL 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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/14/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20190214", "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": "20190311", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8338570", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190122", "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": "312102467", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "SURGEON HAD LOADED THIS PATIENT'S MRI AND CTA INTO PLANNING STATION AND EXPORTED TO ROBOT WITHOUT ISSUE. PATIENT WAS ANESTHETIZED, BUT NO INCISION HAD BEEN MADE. FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO LOAD SERIES FROM O-ARM INTO ROSANNA SOFTWARE. THE SURGEON DETECTED NOISE ON RE-CONSTRUCTION, AND WANTED TO RE-LOAD SERIES WITHOUT INCLUDING ALL SLICES. MULTIPLE WINDOWS SHUTDOWNS OCCURRED. ATTEMPTING TO IMPORT THE SCAN CAUSED ISSUES. THE FSE DELETED SERIES IN ROSANNA EXAM MANAGER, BUT WAS STILL UNABLE TO LOAD. TO TROUBLESHOOT, FSE ATTEMPTED TO MANUALLY DELETE SERIES FROM PATIENT FOLDER USING MAINTENANCE LOG-IN. FSE CONTINUED TO RECEIVE \"IMPOSSIBLE TO LOAD\" ERROR. PATIENT FOLDER WAS THEN RE-IMPORTED FROM SURGEON'S FLASH DRIVE AND OVERWRITTEN TO THE ORIGINAL PATIENT FOLDER. DURING SURGERY, THE SURGEON WANTED TO VIEW MRI AND CTA ON SCREEN DURING GUIDANCE MODE. A WINDOWS ERROR OCCURRED, AND THE USER NEEDED TO RESTART ROSANNA/ MARIO. SHUTDOWN RESULTED IN A 10MIN DELAY (APPROX.), FROM SHUTDOWN AND RESTART TO RESUME GUIDANCE. THE SURGEON REQUESTED TO VIEW MRI FOR ADDITIONAL PLANNING, AND A SHUTDOWN OCCURRED (7MIN DELAY APPROX.). OVERALL DELAY FROM SHUTDOWNS: 1 HOUR 8 MINUTES. AT END OF CASE, THE FSE ATTEMPTED TO VIEW MRI, AND A SHUTDOWN OCCURRED. THE FSE WAS ABLE TO VIEW MRI UPON FULL RESTART WITHOUT ISSUE." }, { "mdr_text_key": "312102468", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT MULTIPLE SHUTDOWNS OCCURRED. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID IDENTIFY 1 SIMILAR COMPLAINT WITHIN THE PAST 6 MONTHS WITH THE SAME ROOT CAUSE FOR THIS DEVICE. THE ANALYSIS OF DATA DETERMINED THAT THE USER TRIED MULTIPLE TIMES TO LOAD AND DISPLAY THE EXAM 1, ITS RESOLUTION IS 563X573 PIXELS. THE SEVEN DEVICE SHUTDOWNS, DURING THE LOAD AND/OR THE DISPLAY OF EXAMS, WERE DUE TO A CRASH OF ROSANNA_BRAIN APPLICATION. THESE ISSUES WERE PROVOKED BY THE LOAD OF AN OVERSIZED EXAM WHICH ALTERED THE COMPUTER PERFORMANCE PROVOKING A LACK OF AVAILABLE MEMORY. AS THE IFU REVIEW INDICATES THAT THE NUMBER OF SLICES MUST BE BETWEEN 100 AND 255 AND THE MAXIMUM RESOLUTION OF IMAGES HAS TO BE 512X512 PIXELS FOR MRI AND CT SCAN AS INDICATING IN THE IFU, THE ROOT CAUSE IDENTIFIED IS A USE ERROR. PATIENT CODE :3191 - NO CODE AVAILABLE : THE EVENT DELAYED THE SURGERY BY MORE THAN AN HOUR." }, { "mdr_text_key": "136115701", "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.  (B)(4)." }, { "mdr_text_key": "136115702", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "SURGEON HAD LOADED THIS PATIENT'S MRI AND CTA INTO PLANNING STATION AND EXPORTED TO ROBOT WITHOUT ISSUE. PATIENT WAS ANESTHETISED, BUT NO INCISION HAD BEEN MADE. FIELD SERVICE ENGINEER (FSE) ATTEMPTED TO LOAD SERIES FROM O-ARM INTO ROSANNA SOFTWARE. THE SURGEON DETECTED NOISE ON RE-CONSTRUCTION, AND WANTED TO RE-LOAD SERIES WITHOUT INCLUDING ALL SLICES. MULTIPLE (B)(6) SHUTDOWNS OCCURRED. ATTEMPTING TO IMPORT THE SCAN CAUSED ISSUES. THE FSE DELETED SERIES IN ROSANNA EXAM MANAGER, BUT WAS STILL UNABLE TO LOAD. TO TROUBLESHOOT, FSE ATTEMPTED TO MANUALLY DELETE SERIES FROM PATIENT FOLDER USING MAINTENANCE LOG-IN. FSE CONTINUED TO RECEIVE \"IMPOSSIBLE TO LOAD\" ERROR. PATIENT FOLDER WAS THEN RE-IMPORTED FROM SURGEON'S FLASH DRIVE AND OVERWRITTEN TO THE ORIGINAL PATIENT FOLDER. DURING SURGERY, THE SURGEON WANTED TO VIEW MRI AND CTA ON SCREEN DURING GUIDANCE MODE. A (B)(6) ERROR OCCURRED, AND THE USER NEEDED TO RESTART ROSANNA/MARIO. SHUTDOWN RESULTED IN A 10MIN DELAY (APPROX.), FROM SHUTDOWN AND RESTART TO RESUME GUIDANCE. THE SURGEON REQUESTED TO VIEW MRI FOR ADDITIONAL PLANNING, AND A SHUTDOWN OCCURRED (7MIN DELAY APPROX.). OVERALL DELAY FROM SHUTDOWNS: 1 HOUR 8 MINUTES. AT END OF CASE, THE FSE ATTEMPTED TO VIEW MRI, AND A SHUTDOWN OCCURRED. THE FSE WAS ABLE TO VIEW MRI UPON FULL RESTART WITHOUT ISSUE." } ], "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": "03/12/2019" } ] }