{ "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": "3009185973-2019-00003", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190117", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20181220", "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": "20190117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "51688", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190117", "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 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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/05/2019", "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": "20190117", "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": "20190306", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8256641", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20181220", "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": "312101355", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON WITH AN RNS CASE ON (B)(6) 2018 USING ROBOT BR18054. AFTER TWO COMMUNICATION ERROR SHUTDOWNS, THE SURGEON WANTED TO UPLOAD A SET OF IMAGES TO THE PLAN THAT WAS ON A CD. THE PATIENT WAS UNDER ANESTHESIA, NO INCISIONS WERE MADE. AROUND 10AM EST, THE CD WAS SELECTED FOR PULLING THE IMAGES OFF OF, BUT THE LOADING OF ALL THE SERIES WAS TAKING VERY LONG. THE PROGRESS FROM 0% TO 100% FOR UPLOADING THE SCAN WAS TAKING A VERY LONG TIME, AS IF THE PC WAS NOT PERFORMING AT IT'S BEST. THE FSE NOTICED THE LIGHT FOR THE EMERGENCY BUTTON WAS RED DURING THIS PROCESS, WHICH COULD HAVE BEEN AN INDICATION THAT SOMETHING WAS WRONG. AFTER WAITING AROUND 55 MINUTES FOR THE IMAGES TO UPLOAD, THE ROBOT EXPERIENCED A SHUTDOWN DUE TO THE PROGRAM NOT RESPONDING MESSAGE APPEARING AROUND 10:55AM EST. THIS CAUSED A SHUTDOWN OF THE ROBOT. THE FSE WAITED A FEW MINUTES TO TURN THE ROBOT BACK ON AFTER SHUTTING IT DOWN. AFTER THE RESTART, THE FSE WAS ABLE TO SELECT THE ONE SERIES OF IMAGES FROM THE DISC THAT THE SURGEON WAS INTERESTED IN BY ACCESSING THE DATA FROM THE DISC THROUGH THE PACS SELECTION. THE IMAGES WERE UPLOADED AND MERGED TO THE PLAN, AND EVERYTHING WORKED FINE AFTER THAT." }, { "mdr_text_key": "312101356", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IMAGES DOWNLOADING ON THE ROBOT WAS UNEXPECTEDLY LONG. A DHR REVIEW AND A COMPLAINT HISTORY REVIEW WERE PERFORMED AND DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ANALYSIS OF DATA LOGS DETERMINED THAT A SINGLE SHUTDOWN OCCURRED DUE TO A ROSANNA_BRAIN APPLICATION CRASH HOWEVER THE CAUSE OF THIS CRASH CANNOT BE DETERMINED. (B)(4)." }, { "mdr_text_key": "133341858", "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": "133341859", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) ASSISTED THE SURGEON WITH AN RNS CASE ON (B)(6) 2018, USING ROBOT (B)(4). AFTER TWO COMMUNICATION ERROR SHUTDOWNS, THE SURGEON WANTED TO UPLOAD A SET OF IMAGES TO THE PLAN THAT WAS ON A CD. THE PATIENT WAS UNDER ANESTHESIA; NO INCISIONS WERE MADE. AROUND 10AM EST, THE CD WAS SELECTED FOR PULLING THE IMAGES OFF OF, BUT THE LOADING OF ALL THE SERIES WAS TAKING VERY LONG. THE PROGRESS FROM 0% TO 100% FOR UPLOADING THE SCAN WAS TAKING A VERY LONG TIME, AS IF THE PC WAS NOT PERFORMING AT ITS BEST. THE FSE NOTICED THE LIGHT FOR THE EMERGENCY BUTTON WAS RED DURING THIS PROCESS, WHICH COULD HAVE BEEN AN INDICATION THAT SOMETHING WAS WRONG. AFTER WAITING AROUND 55 MINUTES FOR THE IMAGES TO UPLOAD, THE ROBOT EXPERIENCED A SHUTDOWN DUE TO THE PROGRAM NOT RESPONDING MESSAGE APPEARING AROUND 10:55AM EST. THIS CAUSED A SHUTDOWN OF THE ROBOT. THE FSE WAITED A FEW MINUTES TO TURN THE ROBOT BACK ON AFTER SHUTTING IT DOWN. AFTER THE RESTART, THE FSE WAS ABLE TO SELECT THE ONE SERIES OF IMAGES FROM THE DISC THAT THE SURGEON WAS INTERESTED IN BY ACCESSING THE DATA FROM THE DISC THROUGH THE PACS SELECTION. THE IMAGES WERE UPLOADED AND MERGED TO THE PLAN, AND EVERYTHING WORKED FINE AFTER THAT." } ], "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": "03/06/2019" } ] }