{ "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": "3009185973-2019-00004", "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": "51696", "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": "01/30/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250727", "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": "20190227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8256646", "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": "311684931", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT 2 COMMUNICATION ERRORS OCCURRED DURING SURGERY. 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 DETERMINED THAT THE CAUSE OF THE FIRST SHUTDOWN IS A USE ERROR, THE SURGEON APPLIED TOO MUCH FORCE ON THE ROBOT ARM. A REVIEW OF THE IFU INDICATES THAT WARNINGS ARE PROVIDED. THE CAUSE OF THE SECOND SHUTDOWN IS A SHARED MEMORY ERROR BETWEEN ROSANNA_BRAIN AND MARIO SOFTWARE. UNIQUE IDENTIFIER (UDI) NUMBER : (B)(4). PATIENT CODE(S) : 3191 - NO CODE AVAILABLE : THE TWO REPORTED EVENTS DELAYED THE SURGERY, ADDING UP TO ONE HOUR TO THE PROCEDURE. CORRECTED DATA: DATE OF THIS REPORT, DATE RECEIVED BY MANUFACTURER, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MANUFACTURER, EVALUATION CODE." }, { "mdr_text_key": "311684932", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS ASSISTING THE SURGEON WITH AN RNS CASE USING ROBOT BR18054. BONE FIDUCIALS WERE USED FOR REGISTRATION, SO THE POINTER INSTRUMENT WAS BEING USED. AROUND 9:52AM EST, AFTER SUCCESSFUL REGISTRATION OF THE PATIENT, THE ROBOT EXPERIENCED A COMMUNICATION ERROR DURING THE VERIFICATION PORTION OF REGISTRATION. THE SURGEON MOVED THE ARM IN FREE/FAST MODE TO THE PATIENT'S SKIN ON THE SKULL TO VERIFY THE ACCURACY OF REGISTRATION. THE SURGEON FELT THE ARM LOCK WHEN REACHING THE PATIENT'S SKIN AND AN AUDIBLE CLICK NOISE WAS HEARD. THE MESSAGE COMMUNICATION FAILURE WITH THE ROBOT. THE SYSTEM WILL SHUT DOWN APPEARED ON THE SCREEN, AND THE ROBOT WAS FORCED TO RESTART. THE POINTER WAS TOUCHING THE PATIENT'S SKIN, BUT WAS NOT STUCK IN A POSITION THAT WOULD BE AN ISSUE FOR THE PATIENT. AROUND 9:55AM EST, AFTER RESTARTING THE ROBOT, THE SURGEON ATTEMPTED TO MOVE THE POINTER OUT OF THE WAY TO RESTART THE VERIFICATION. WHEN THE FSE SWITCHED TO VERIFICATION AND TO PUT THE ARM MOVEMENT AT FREE AND FAST, ANOTHER COMMUNICATION ERROR OCCURRED WITH THE SAME AUDIBLE CLICK AND MESSAGE ON SCREEN AS BEFORE. THERE WAS ALSO AN ADDITIONAL MESSAGE THAT SAID IMPOSSIBLE TO MODIFY COOPERATIVE MODE PARAMETERS. THE ROBOT WAS SHUT DOWN FOR A SECOND TIME. THE SURGEON DECIDED TO DETACH THE PATIENT FROM ROSA, SO THE ROBOT COULD BE BACKED AWAY AND THE POINTER INSTRUMENT COULD SAFELY BE REMOVED. THIS CAUSED THE REGISTRATION TO BE NULL AND A NEW REGISTRATION NEEDED TO BE DONE. A SEPARATE COMPLAINT CAUSED AN ADDITIONAL DELAY, BUT AFTER THIS WAS RESOLVED, THE NEW REGISTRATION WAS PERFORMED AND THERE WERE NO ADDITIONAL ISSUES. TOTAL DELAY FOR THIS COMPLAINT WAS LESS THAN 15 MINUTES." }, { "mdr_text_key": "133342338", "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": "133342339", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) WAS ASSISTING THE SURGEON WITH AN RNS CASE USING ROBOT (B)(4). BONE FIDUCIALS WERE USED FOR REGISTRATION, SO THE POINTER INSTRUMENT WAS BEING USED. AROUND 9:52AM EST, AFTER SUCCESSFUL REGISTRATION OF THE PATIENT, THE ROBOT EXPERIENCED A COMMUNICATION ERROR DURING THE VERIFICATION PORTION OF REGISTRATION. THE SURGEON MOVED THE ARM IN FREE/FAST MODE TO THE PATIENT'S SKIN ON THE SKULL TO VERIFY THE ACCURACY OF REGISTRATION. THE SURGEON FELT THE ARM LOCK WHEN REACHING THE PATIENT'S SKIN AND AN AUDIBLE CLICK NOISE WAS HEARD. THE MESSAGE \"COMMUNICATION FAILURE WITH THE ROBOT. THE SYSTEM WILL SHUT DOWN\" APPEARED ON THE SCREEN, AND THE ROBOT WAS FORCED TO RESTART. THE POINTER WAS TOUCHING THE PATIENT'S SKIN, BUT WAS NOT STUCK IN A POSITION THAT WOULD BE AN ISSUE FOR THE PATIENT. AROUND 9:55AM EST, AFTER RESTARTING THE ROBOT, THE SURGEON ATTEMPTED TO MOVE THE POINTER OUT OF THE WAY TO RESTART THE VERIFICATION. WHEN THE FSE SWITCHED TO VERIFICATION AND TO PUT THE ARM MOVEMENT AT FREE AND FAST, ANOTHER COMMUNICATION ERROR OCCURRED WITH THE SAME AUDIBLE CLICK AND MESSAGE ON SCREEN AS BEFORE. THERE WAS ALSO AN ADDITIONAL MESSAGE THAT SAID IMPOSSIBLE TO MODIFY COOPERATIVE MODE PARAMETERS. THE ROBOT WAS SHUT DOWN FOR A SECOND TIME. THE SURGEON DECIDED TO DETACH THE PATIENT FROM ROSA, SO THE ROBOT COULD BE BACKED AWAY AND THE POINTER INSTRUMENT COULD SAFELY BE REMOVED. THIS CAUSED THE REGISTRATION TO BE NULL AND A NEW REGISTRATION NEEDED TO BE DONE. A SEPARATE COMPLAINT CAUSED AN ADDITIONAL DELAY, BUT AFTER THIS WAS RESOLVED, THE NEW REGISTRATION WAS PERFORMED AND THERE WERE NO ADDITIONAL ISSUES. TOTAL DELAY FOR THIS COMPLAINT WAS LESS THAN 15 MINUTES." } ], "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": "02/28/2019" } ] }