{ "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": "3009185973-2021-00098", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210409", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210324", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "BE", "manufacturer_contact_area_code": "", "date_added": "20210409", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "536880", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210409", "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": "ROSAS00201", "lot_number": "3.1.4.1650", "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": [ "Unintended Application Program Shut Down", "Unintended Application Program Shut Down" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/22/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20210409", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210507", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11640536", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210324", "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": "324907818", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DETAILED ANALYSIS OF THE DATA LOGS FROM THE SUBJECT EVENT HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE UNEXPECTED RESTART OF THE DEVICE DURING THE PROCESS IS DUE TO THE VIRTUAL MEMORY MISMANAGEMENT. THIS RESTART HAD FOR CONSEQUENCE THE LOSS OF THE TRAJECTORY 'TRAJECTOIRE 1'. THIS LOSS OF TRAJECTORY IS CONSIDERED AS A NORMAL BEHAVIOR OF THE DEVICE BECAUSE THE PATIENT FOLDER WAS NOT SAVED DURING THE TIME PERIOD BETWEEN THE CREATION OF THE TRAJECTORY AND THE ISSUE RELATED TO THE VIRTUAL MEMORY. THE ISSUES EXPERIENCED WILL BE ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCT. CORRECTED DATA: - B4 DATE OF THIS REPORT. - G3 DATE RECEIVED BY MANUFACTURER. - H2 IF FOLLOW-UP, WHAT TYPE. - H3 DEVICE EVALUATED BY MANUFACTURER. - H6 ADVERSE EVENT PROBLEM. - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "324907819", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, AFTER TWO BIOPSY SAMPLES WERE RETRIEVED THE ROBOT CRASHED AND THE SCREEN WENT BLACK. THE ENTRY AND THE TARGET POINTS WERE LOST, THEREFORE THE USER HAD TO CREATE A NEW TRAJECTORY, WITH A SLIGHTLY DIFFERENT TARGET POINT. DUE TO THIS EVENT, THERE WAS A DELAY OVER 30 MINUTES TO THE SURGERY AND THE PATIENT RECEIVED ADDITIONAL ANESTHETICS." }, { "mdr_text_key": "245988224", "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. UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "245988265", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A SURGERY, AFTER TWO BIOPSY SAMPLES WERE RETRIEVED THE ROBOT CRASHED AND THE SCREEN WENT BLACK. THE ENTRY AND THE TARGET POINTS WERE LOST, THEREFORE THE USER HAD TO CREATE A NEW TRAJECTORY, WITH A SLIGHTLY DIFFERENT TARGET POINT. DUE TO THIS EVENT, THERE WAS A DELAY OVER 30 MINUTES TO THE SURGERY AND THE PATIENT RECEIVED ADDITIONAL ANESTHETICS." } ], "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": "05/07/2021" } ] }