{ "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": "3009185973-2020-00142", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200615", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200527", "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": "CA", "manufacturer_contact_area_code": "", "date_added": "20200615", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "619782", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200615", "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": "ROSAS00216", "lot_number": "3.1.1.1295", "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 Collision", "Unintended Collision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/22/2020", "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": "20200615", "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": "20201026", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10152103", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200526", "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": "321444715", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "AT ROUGHLY 13:05, SURGEON WAS CLEARING ROBOT ARM FROM IMPLANTATION OF DEPTH ELECTRODE, WHEN 'FREE AND FAST' WERE SELECTED ON SCREEN, A SMALL COLLISION OCCURRED BECAUSE THE DRILL ADAPTOR WAS NOT ENTIRELY CLEAR FROM THE DIXI BOLT. SURGEON ATTEMPTED TO CLEAR, BUT A COLLISION AND SHUTDOWN OCCURRED. THE COMPANY FIELD SERVICE ENGINEER INSTRUCTED SURGEON TO SHUTDOWN ROSA ENTIRELY, AND WAIT TO CONNECT TO SOFTWARE. UPON RESTART, COLLISION WAS STILL DETECTED. SURGEON RESTARTED ROSA SYSTEM A SECOND TIME, AND WAS ABLE TO CLEAR ARM. TO PROCEED, SURGEON DROVE BACK TO TRAJECTORY AND CONFIRMED THAT NO SHIFT HAD OCCURRED. CASE PROCEEDED AS PLANNED. DELAY 15 MINUTES, SEEG, PATIENT UNDER ANESTHESIA." }, { "mdr_text_key": "321444716", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT COLLISION OCCURRED IN FAST COOPERATIVE MODE BECAUSE THE DRILL ADAPTOR WAS NOT CLEARED FROM THE BOLT. THE ROBOT ARM GOT STUCK BECAUSE THE TOOL WAS ATTEMPTED TO BE CLEARED IN FAST COOPERATIVE MODE WHEREAS IT WAS TOUCHING AN OBJECT, DUE TO A SOFTWARE ANOMALY. UPON THE FIRST RESTART, A FORCE SENSOR SATURATION WAS STILL DETECTED AND LED TO A SHUTDOWN OF THE ROBOT. REBOOTING THE ROBOT COMPLETELY PERMITTED TO REINITIALIZE THE CONTROLLER AND SOLVED THE PROBLEM. CORRECTED DATA: - B3 DATE OF EVENT . - B4 DATE OF THIS REPORT. - D4 LOT 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": "196908388", "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. UDI: (B)(4). (B)(4) THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT AND TO ANOTHER EVENT THAT OCCURRED DURING THE SAME SURGERY (3009185973-2020-00141)." }, { "mdr_text_key": "196908389", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AT ROUGHLY 13:05, SURGEON WAS CLEARING ROBOT ARM FROM IMPLANTATION OF DEPTH ELECTRODE, WHEN \"FREE AND FAST\" WERE SELECTED ON SCREEN, A SMALL COLLISION OCCURRED BECAUSE THE DRILL ADAPTOR WAS NOT ENTIRELY CLEAR FROM THE DIXI BOLT. SURGEON ATTEMPTED TO CLEAR, BUT A COLLISION AND SHUTDOWN OCCURRED. THE COMPANY FIELD SERVICE ENGINEER INSTRUCTED SURGEON TO SHUTDOWN ROSA ENTIRELY, AND WAIT TO CONNECT TO SOFTWARE. UPON RESTART, COLLISION WAS STILL DETECTED. SURGEON RESTARTED ROSA SYSTEM A SECOND TIME, AND WAS ABLE TO CLEAR ARM. TO PROCEED, SURGEON DROVE BACK TO TRAJECTORY AND CONFIRMED THAT NO SHIFT HAD OCCURRED. CASE PROCEEDED AS PLANNED. DELAY 15 MINUTES, SEEG, PATIENT UNDER ANESTHESIA." } ], "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": "10/27/2020" } ] }