{ "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": "3009185973-2019-00220", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20190702", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190603", "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": "20190702", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "549440", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190702", "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": "N/A", "lot_number": "3.0.0.21", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": [ "Connection Problem", "Connection Problem" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20190702", "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": "20190702", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8753324", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190603", "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": "149800616", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI #: (B)(4). IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO CONNECT TO ROBOT ARM AFTER A SHUTDOWN OF THE DEVICE. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE ROOT CAUSE OF THE EVENT IS A PROBLEM OF THE ARM POSITION, THE JOINT J6 WAS OUT OF ITS LIMITS. TO SOLVE THE PROBLEM, J6 MUST BE MOVED IN ITS RANGE OF ACCESSIBLE POSITION USING THE TEACHING BOX. IF THIS TOOL IS NOT AVAILABLE, IT IS NECESSARY TO CONTACT (B)(4) (ROBOT ARM SUPPLIER). FINALLY, (B)(4) PERFORMED AN INTERVENTION ON THE DEVICE AND THE ROBOT ARM IS NOW FULLY FUNCTIONAL." }, { "mdr_text_key": "149800617", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CUSTOMER WAS IN THE PROCESS OF DOING THE VERIFICATION PROCESS OF THE REGISTRATION, UPON DRIVING TO A FIDUCIAL, CUSTOMER STATED THEY WERE ROTATING THE ARM WHEN IT SHUT DOWN. RECEIVED ERROR OF FAILURE TO COMMUNICATE. THE FIELD SERVICE ENGINEER ARRIVED ON SITE, REBOOTED ROBOT AFTER DOING A THOROUGH SHUTDOWN. FAILURE TO CONNECT TO ROBOT. ATTEMPTED TO CONNECT THROUGH KINEVERIF, OBTAINED ERROR MESSAGE \"FAILED TO TURN SERVOS ON\" FOLLOWED BY \"FAILED TO GET MARIO VERSION\". ATTEMPTED TO MANUALLY RELEASE ROBOT ARM, REBOOTED ROBOT. FAILURE TO CONNECT TO ROBOT MESSAGE OBTAINED AGAIN. CONNECTED TO CONTROLLER, DELETED \"CONFIG\" AND \"TEMP\" FILES. REBOOTED SYSTEM. FAILED TO CONNECT, AT WHICH POINT CST WAS NO LONGER ABLE TO CONNECT TO THE CONTROLLER. FINALLY, ANOTHER ROBOT WAS USED TO PERFORM THE SURGERY, FROM THE NEIGHBORING HOSPITAL. THIS EVENT CAUSED A DELAY GREATER TO 2 HOURS." } ], "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": "" } ] }