{ "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": "3009185973-2019-00355", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20191015", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20190916", "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": "FR", "manufacturer_contact_area_code": "", "date_added": "20191015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "987828", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191015", "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 3.1", "catalog_number": "ROSAS00201", "lot_number": "3.1.0.1276", "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": "07/27/2020", "mfr_report_type": "", "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": "20191015", "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": "20200727", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9189696", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190916", "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": "319950668", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON CALLED THE FIELD SERVICE ENGINEER TO NOTICE THAT THE ROBOT IS NOT USABLE DUE TO UNRECOVERABLE ERROR MESSAGE AND SHUT DOWN. THE MESSAGE APPEAR WHEN THE SYSTEM SHOULD START THE CONNECTION WITH THE ROBOTIC ARM, IN ORDER TO MOVE BETWEEN PARKING TO HOME POSITION. THE SURGERY IS CANCELLED." }, { "mdr_text_key": "319950669", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT THE ARM FAILED TO CONNECT ON THE SURGERY DAY, (B)(6) 2019, ALTHOUGH MANY REBOOTS WERE ATTEMPTED. THE ANALYSIS PERMITTED TO DETERMINE THAT THE CONNECTION BECAME IMPOSSIBLE AFTER A PREVIOUS CASE ON THE (B)(6)2019, DURING WHICH THE STAÜBLI CONTROLLER WAS INCORRECTLY SWITCHED OFF. THEREFORE, THE INCORRECT SHUTDOWN OF THE DEVICE MIGHT HAVE PROVOKED A FAILURE SITUATION IN THE CONTROLLER. HOWEVER, THE PROBLEM WAS SOLVED THE DAY AFTER, ON (B)(6) 2019, BUT THERE IS NO EVIDENCE REGARDING HOW IT WAS SOLVED. IT WAS DETERMINED THAT UPON THE FIRST ATTEMPT, THE CONTROLLER DID NOT INITIATE WHEN THE DEVICE WAS BOOTED. THE ISSUE IS KNOWN AND ACCORDING TO STAÜBLI, IT IS DUE TO THE VERSION OF THE SOURCE CODE IN THE CONTROLLER. THE EMERGENCY BUTTON WAS ALSO ACTIVATED ONCE, BUT THERE ARE NO EVIDENCE TO DETERMINE WHETHER IT WAS DISABLED THEREAFTER OR TO EXPLAIN THE CAUSE FOR THE REPEATED CONNECTION FAILURE OF THE ARM. 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." }, { "mdr_text_key": "162469012", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI :(B)(4). PATIENT CODE (B)(4) WAS CHOSEN AS THE REPORTER STATED THAT THE SURGERY WAS CANCELLED. THE OBSERVED CONSEQUENCE IS CONSIDERED AS A SERIOUS INJURY." }, { "mdr_text_key": "162469013", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON CALLED THE FIELD SERVICE ENGINEER TO NOTICE THAT THE ROBOT IS NOT USABLE DUE TO UNRECOVERABLE ERROR MESSAGE AND SHUT DOWN. THE MESSAGE APPEAR WHEN THE SYSTEM SHOULD START THE CONNEXION WITH THE ROBOTIC ARM, IN ORDER TO MOVE BETWEEN PARKING TO HOME POSITION. THE SURGERY IS CANCELLED." } ], "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": "07/28/2020" } ] }