{ "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": "3009185973-2020-00052", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200214", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200204", "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": "20200214", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "174759", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200214", "brand_name": "ROSA ONE", "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 ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "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", "Loss of Data", "Computer Software Problem", "Loss of Data" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/28/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20200214", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Code Available", "No Consequences Or Impact To Patient", "No Code Available" ] } ], "distributor_city": "", "date_report": "20200429", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9710616", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200204", "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": "318000163", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. AN ANALYSIS OF THE DATA LOGS FROM THE SUBJECT EVENT HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT: (1) THE CRASH OF THE SOFTWARE IS ASSUMED TO BE DUE TO A SOFTWARE ANOMALY. THE WORKFLOW REPRODUCTION ON A SIMULATOR PERMITTED TO REPRODUCE THE CRASH EVENT FOR THE MRI SEGMENTATION AND NOT FOR CT. THEREFORE, THE CRASH IS ASSUMED TO BE A RANDOM CONSEQUENCE OF THE SOFTWARE ANOMALY. THE DISAPPEARANCE OF THE PATIENT FOLDER IS DUE TO THAT IT NO LONGER CONTAINED ANY EXAM DEFINED AS 3D REFERENCE WHICH IS NECESSARY FOR THE CORRECT READING OF A PATIENT FOLDER. THE PATIENT FOLDER WAS SAVED WITH NO EXAM DEFINED AS 3D REFERENCE. THIS IS A SOFTWARE ANOMALY. (2) THE CAUSE FOR THE UNSUCCESSFUL LOADING OF THE MRI VIA THE CD IS DUE TO THAT AN UNSUPPORTED EXAM TYPE WAS ALSO CONTAINED ON IT. THE SOFTWARE CRASHED AFTER THE END OF THE CD READING. THIS IS A SOFTWARE ANOMALY. CORRECTED DATA: B4 DATE OF THIS REPORT, G4 DATE RECEIVED BY MANUFACTURER, H2 IF FOLLOW-UP, WHAT TYPE, H3 DEVICE EVALUATED BY MANUFACTURER, H6 EVENT PROBLEM AND EVALUATION CODES, AND H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "318000164", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING EVENTS OCCURRED DURING AN ABLATION CASE WITH COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTING. (1) AT APPROXIMATELY 7:52 AM AFTER THE MANUAL SCANS DURING REGISTRATION, THE SOFTWARE DETECTED SIGNIFICANT ERRORS RESULTING IN A RE-START OF THE REGISTRATION. WHEN ADJUSTING THE 3D RECONSTRUCTION OF THE CT SCAN, THE FSE, PROCEEDED TO HIT COMPUTE AND VALIDATE. THE REGISTRATION TAB WAS THEN PRESSED, AND AT THIS TIME, THE ERROR 'ROSANNA BRAIN.EXE HAS STOPPED RESPONDING' POPULATED THE SCREEN AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THE FSE THEN TURNED ON THE ROBOT. AFTER CLICKING THE LOAD THE PATIENT FOLDER TAB, IT WAS DISCOVERED THAT THE NEEDED PATIENT FOLDER (THAT HAD JUST BEEN USED) WAS MISSING AND OR DELETED FROM THE ROSA ROBOT. IT SHOULD BE NOTED THAT IT WAS THE ONLY PATIENT FOLDER MISSING FROM THE ROSA AND PAST PLANS (FOR PREVIOUS PATIENTS) WERE STILL ACCESSIBLE. THE FSE TRIED RESTARTING THE ROSA ROBOT AND THE ISSUE PERSISTED. THE FSE THEN LOGGED INTO THE MAINTENANCE SIDE OF THE ROBOT, AND FOUND THE PATIENT FOLDER IN D:/MEDTECH/DATA/PATIENT FOLDER AND COPIED IT TO A USB. THE FSE THEN LOGGED BACK INTO ROSA BRAIN, HOWEVER AGAIN THE PATIENT FOLDER WOULD NOT POPULATE AND WAS STILL INACCESSIBLE IN THE SOFTWARE. THE SURGEONS, PROCEEDED TO HAVE TO RE-PLAN THE TRAJECTORIES FOR THE CASE. THIS DELAY TOOK APPROXIMATELY 2 HOURS. (2) WHEN RE-PLANNING FOR THE CASE (AS MENTIONED ABOVE), THE FSE HAD TO RELOAD THE IMAGING FOR THE PATIENT VIA A CD. WHEN TRYING TO LOAD THE MRI VIA THE CD AGAIN THE ERROR 'ROSA BRAIN.EXE HAS STOPPED RESPONDING' OCCURRED AND SHUTDOWN THE ROSA SOFTWARE. THE ROSA WAS THEN RESTARTED AND THE PROCESS WAS AGAIN TRIED, WITH THE SAME ERROR OCCURRING. FINALLY, THE FSE TRIED LOADING THE SCAN OFF THE CD VIA IQVIEW. THE MRI WAS THEN SUCCESSFULLY ABLE TO BE LOADED INTO THE SOFTWARE AND PLANNING WAS ABLE TO PROCEED AS NORMAL. THIS RESULTED IN AN APPROXIMATE 10 MINUTE DELAY." }, { "mdr_text_key": "189881684", "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": "189881685", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FOLLOWING EVENTS OCCURRED DURING AN ABLATION CASE WITH COMPANY FIELD SERVICE ENGINEER (FSE) ASSISTING. (1) AT APPROXIMATELY 7:52 AM AFTER THE MANUAL SCANS DURING REGISTRATION, THE SOFTWARE DETECTED SIGNIFICANT ERRORS RESULTING IN A RE-START OF THE REGISTRATION. WHEN ADJUSTING THE 3D RECONSTRUCTION OF THE CT SCAN, THE FSE, PROCEEDED TO HIT COMPUTE AND VALIDATE. THE REGISTRATION TAB WAS THEN PRESSED, AND AT THIS TIME, THE ERROR 'ROSANNA BRAIN.EXE HAS STOPPED RESPONDING' POPULATED THE SCREEN AND THE ROSA ROBOT PROCEEDED TO SHUT DOWN. THE FSE THEN TURNED ON THE ROBOT. AFTER CLICKING THE LOAD THE PATIENT FOLDER TAB, IT WAS DISCOVERED THAT THE NEEDED PATIENT FOLDER (THAT HAD JUST BEEN USED) WAS MISSING AND OR DELETED FROM THE ROSA ROBOT. IT SHOULD BE NOTED THAT IT WAS THE ONLY PATIENT FOLDER MISSING FROM THE ROSA AND PAST PLANS (FOR PREVIOUS PATIENTS) WERE STILL ACCESSIBLE. THE FSE TRIED RESTARTING THE ROSA ROBOT AND THE ISSUE PERSISTED. THE FSE THEN LOGGED INTO THE MAINTENANCE SIDE OF THE ROBOT, AND FOUND THE PATIENT FOLDER IN D:/MEDTECH/DATA/PATIENT FOLDER AND COPIED IT TO A USB. THE FSE THEN LOGGED BACK INTO ROSA BRAIN, HOWEVER AGAIN THE PATIENT FOLDER WOULD NOT POPULATE AND WAS STILL INACCESSIBLE IN THE SOFTWARE. THE SURGEONS, PROCEEDED TO HAVE TO RE-PLAN THE TRAJECTORIES FOR THE CASE. THIS DELAY TOOK APPROXIMATELY 2 HOURS. (2) WHEN RE-PLANNING FOR THE CASE (AS MENTIONED ABOVE), THE FSE HAD TO RELOAD THE IMAGING FOR THE PATIENT VIA A CD. WHEN TRYING TO LOAD THE MRI VIA THE CD AGAIN THE ERROR 'ROSA BRAIN.EXE HAS STOPPED RESPONDING' OCCURRED AND SHUTDOWN THE ROSA SOFTWARE. THE ROSA WAS THEN RESTARTED AND THE PROCESS WAS AGAIN TRIED, WITH THE SAME ERROR OCCURRING. FINALLY, THE FSE TRIED LOADING THE SCAN OFF THE CD VIA IQVIEW. THE MRI WAS THEN SUCCESSFULLY ABLE TO BE LOADED INTO THE SOFTWARE AND PLANNING WAS ABLE TO PROCEED AS NORMAL. THIS RESULTED IN AN APPROXIMATE 10 MINUTE DELAY." } ], "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": "04/29/2020" } ] }