{ "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": "3009185973-2019-00092", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190314", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190213", "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": "20190314", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "214352", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190314", "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", "catalog_number": "ROSAS00303", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/22/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20190314", "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": "20201023", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8419442", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190213", "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": "138763468", "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). UNIQUE IDENTIFIER (UDI) #: (B)(4)." }, { "mdr_text_key": "138763469", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING A SURGERY, WHILE MOVING TO ONE OF THE TRAJECTORIES, THE ROBOT ARM HIT THE MAYFIELD HEAD HOLDER. THE ROBOT SHUT DOWN AND WAS RESTARTED. GUIDANCE MODE WAS SELECTED TO CONNECT TO THE ARM; HOWEVER, THE ARM CLICKED ONCE FOR THE CONNECTION AND AGAIN TWICE AND AN ERROR MESSAGE APPEARED FOR THE COMMUNICATION ERROR. WHILE THE ERROR MESSAGE ASKING TO SAVE THE PATIENT FOLDER AND SHUT DOWN THE ROBOT WAS VISIBLE, ANOTHER MESSAGE APPEARED ASKING WHAT DEVICE WAS ON THE ARM. INSTRUMENT HOLDER WAS SELECTED AND CALIBRATED AND IT WAS ATTEMPTED TO MOVE THE ARM OUT OF THE WAY; HOWEVER, ANOTHER ERROR MESSAGE STATED THAT THE COOPERATIVE MOVEMENT COULD NOT BE PERFORMED. FOLLOWING THIS MESSAGE, THE ROBOT WAS SHUT DOWN. THE ROBOT WAS RESTARTED AGAIN AND A CONNECTION WAS ATTEMPTED; HOWEVER, THE SAME ERROR MESSAGES APPEARED. THE SIDE PANEL WAS REMOVED FROM THE ROBOT TO TRY TO RELEASE THE ARM IN MANUAL MODE. SEVERAL ATTEMPTS WERE MADE TO MOVE EACH JOINT; HOWEVER, ALL OF THE JOINTS WERE FIRMLY LOCKED IN PLACE AND WOULD NOT MOVE. IT WAS THEN ATTEMPTED TO ROTATE THE MAYFIELD HEAD HOLDER AWAY FROM THE ARM TO GIVE CLEARANCE FOR THE ARM TO CONNECT. THE SURGEON DREW TWO BLACK MARKS ON THE MAYFIELD HEAD HOLDER AND MAYFIELD ADAPTOR TO RESCREW THE HEAD HOLDER BACK IN THE SAME LOCATION. THE ROBOT WAS TURNED ON AND THEN THE MAYFIELD HEAD HOLDER WAS UNSCREWED AS THE SURGEON HELD THE PATIENT'S HEAD AND THE FRAME WAS MOVED AWAY FROM THE ARM. THE ARM WAS ABLE TO CONNECT AND WAS MOVED TO THE HOME POSITION AFTER BEING CLEARED. THE HEAD HOLDER WAS RECONNECTED TO THE PATIENT. THE ARM WAS DRIVEN BACK TO THE FIRST IMPLANTED TRAJECTORY; HOWEVER, THE ADAPTOR POINTED TO A LOCATION SEVERAL MILLIMETERS AWAY FROM THE ORIGINAL IMPLANT. SINCE THE ACCURACY WAS SIGNIFICANTLY OFF, THE STERILE DRAPES WERE REMOVED AND LASER REGISTRATION WAS RE-PERFORMED." }, { "mdr_text_key": "321334829", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THERE WAS A ROBOT ARM COLLISION WITH THE MAYFIELD HEAD HOLDER NEAR JOINT 4 OF THE ARM. THEN, THE ROBOT ARM WAS NOT MOVEABLE ANYMORE. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND LED TO THE FOLLOWING OBSERVATIONS : THE FIRST COMMUNICATION ERROR OCCURRED DURING GUIDANCE MODE, WHEN THE COOPERATIVE MODE WAS LAUNCHED, DUE TO A COLLISION OF THE ROBOT ARM WITH THE MAYFIELD HEAD HOLDER. IT COULD HAVE BEEN AVOIDED BY RELEASING THE PEDAL BEFORE THE COLLISION, AS EXPLAINED IN THE IFUS. THE USER IS RESPONSIBLE FOR THE MONITORING OF THE ROBOT ARM MOTION THROUGHOUT THE WHOLE PROCEDURE, AND THIS ISSUE CAN BE CONSIDERED AS A USE ERROR. THE FOUR OTHERS COMMUNICATION ERRORS WERE DUE TO THE PREVIOUS COLLISION AS THE ARM WAS VERY LIKELY STILL IN CONTACT WITH THE MAYFIELD HEAD HOLDER. THE CONTROLLER DETECTED A DEFAULT SITUATION ON THE AXIS PREVIOUSLY INVOLVED IN THE COLLISION. THIS CAUSED THE SHUTDOWN OF THE DEVICE WHICH IS A NORMAL BEHAVIOR. FURTHERMORE, ACCORDING TO THE COMPLAINT DESCRIPTION, THE FSE TRIED TO MOVE MANUALLY THE ROBOT USING THE MANUAL BRAKE BUTTON BUT ALL OF THE JOINTS WERE FIRMLY LOCKED IN PLACE AND WOULD NOT MOVE. THIS ISSUE PROBABLY OCCURRED BECAUSE THE JOINTS WERE STILL IN A LOCKED POSITION DUE TO THE COLLISION. TO SOLVE THIS ISSUE, THE CONTROLLER MUST NO LONGER BE IN DEFAULT WHEN IT IS STARTED, THEREFORE THE INSTRUMENT MUST BE REMOVED FROM THE ROBOT ARM, OR THE PATIENT HEAD MUST BE MOVED, OR THE CONTROLLER MUST BE REINITIALIZED BY PRESSING THE ON/OFF SWITCH ON THE ITS FRONT PANEL. EVENTUALLY, THE MAYFIELD HEAD HOLDER WAS DISCONNECTED FROM THE ROBOT AND THE ARM COULD BE CLEARED AWAY FROM THE PATIENT HEAD. THE LASER REGISTRATION HAD TO BE REPEATED, AND THE PROCEDURE COULD BE RESUMED. OTHER THAN THE REPORTED DELAY, THERE WAS NO CONSEQUENCE FOR THE PATIENT. CORRECTED DATA: B1 REPORT TYPE; B4 DATE OF THIS REPORT; D4 CATALOG NUMBER; G4 DATE RECEIVED BY MANUFACTURER; H2 IF FOLLOW-UP, WHAT TYPE; H3 DEVICE EVALUATED BY MANUFACTURER; H6 EVENT PROBLEM AND EVALUATION CODES; H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "321334830", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A SURGERY, WHILE MOVING TO ONE OF THE TRAJECTORIES, THE ROBOT ARM HIT THE MAYFIELD HEAD HOLDER. THE ROBOT SHUT DOWN AND WAS RESTARTED. GUIDANCE MODE WAS SELECTED TO CONNECT TO THE ARM; HOWEVER, THE ARM CLICKED ONCE FOR THE CONNECTION AND AGAIN TWICE AND AN ERROR MESSAGE APPEARED FOR THE COMMUNICATION ERROR. WHILE THE ERROR MESSAGE ASKING TO SAVE THE PATIENT FOLDER AND SHUT DOWN THE ROBOT WAS VISIBLE, ANOTHER MESSAGE APPEARED ASKING WHAT DEVICE WAS ON THE ARM. INSTRUMENT HOLDER WAS SELECTED AND CALIBRATED AND IT WAS ATTEMPTED TO MOVE THE ARM OUT OF THE WAY; HOWEVER, ANOTHER ERROR MESSAGE STATED THAT THE COOPERATIVE MOVEMENT COULD NOT BE PERFORMED. FOLLOWING THIS MESSAGE, THE ROBOT WAS SHUT DOWN. THE ROBOT WAS RESTARTED AGAIN AND A CONNECTION WAS ATTEMPTED; HOWEVER, THE SAME ERROR MESSAGES APPEARED. THE SIDE PANEL WAS REMOVED FROM THE ROBOT TO TRY TO RELEASE THE ARM IN MANUAL MODE. SEVERAL ATTEMPTS WERE MADE TO MOVE EACH JOINT; HOWEVER, ALL OF THE JOINTS WERE FIRMLY LOCKED IN PLACE AND WOULD NOT MOVE. IT WAS THEN ATTEMPTED TO ROTATE THE MAYFIELD HEAD HOLDER AWAY FROM THE ARM TO GIVE CLEARANCE FOR THE ARM TO CONNECT. THE SURGEON DREW TWO BLACK MARKS ON THE MAYFIELD HEAD HOLDER AND MAYFIELD ADAPTOR TO RESCREW THE HEAD HOLDER BACK IN THE SAME LOCATION. THE ROBOT WAS TURNED ON AND THEN THE MAYFIELD HEAD HOLDER WAS UNSCREWED AS THE SURGEON HELD THE PATIENT'S HEAD AND THE FRAME WAS MOVED AWAY FROM THE ARM. THE ARM WAS ABLE TO CONNECT AND WAS MOVED TO THE HOME POSITION AFTER BEING CLEARED. THE HEAD HOLDER WAS RECONNECTED TO THE PATIENT. THE ARM WAS DRIVEN BACK TO THE FIRST IMPLANTED TRAJECTORY; HOWEVER, THE ADAPTOR POINTED TO A LOCATION SEVERAL MILLIMETERS AWAY FROM THE ORIGINAL IMPLANT. SINCE THE ACCURACY WAS SIGNIFICANTLY OFF, THE STERILE DRAPES WERE REMOVED AND LASER REGISTRATION WAS RE-PERFORMED." } ], "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": "10/23/2020" } ] }