{ "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": "3009185973-2020-00180", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200729", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200707", "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": "20200729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "804480", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200729", "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": "ROSAS00203", "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": [ "Connection Problem", "Connection Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/25/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20200729", "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": "20201125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10338099", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200707", "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": "321362844", "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 THE ROBOT ARM WAS NOT ABLE TO CONNECT BECAUSE THE TWO SECURITY CONTACTS OF THE EMERGENCY STOP BUTTON DID NOT WORK AS INTENDED ON THIS OCCASION. THE EMERGENCY STOP BUTTON WAS INDEED ACTIVATED BEFORE THE MULTIPLE MANUAL RELEASE ATTEMPTS PERFORMED BY THE FIELD ENGINEER. THE DELETION OF TWO SPECIFIC CONTROLLER FILES SOLVED THE ISSUE WITH NO INCIDENCE ON THE DEVICE OPERATION OR ON THE EMERGENCY STOP BUTTON FUNCTIONALITY. 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. - H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "321362845", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING SECOND ATTEMPT AT REGISTRATION, ROSA WAS PERFORMING AUTOMATIC SCANNING PORTION OF CONTACTLESS REGISTRATION. ARM DISCONNECTED, AND SHUTDOWN ERROR OCCURRED. ROBOT WAS SHUTDOWN AND THEN RESTARTED. ROBOT WAS UNABLE TO RECONNECT TO ARM, SO SHUTDOWN OCCURRED AGAIN. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED SEVERAL SHUTDOWNS, WITHOUT SUCCESS. ROBOT WAS REMOVED FROM PATIENT, AND MANUAL RELEASE WAS ATTEMPTED OUTSIDE OF OR. ARM WAS STILL UNABLE TO CONNECT. THE FSE CONTINUED TO PERFORM MANUAL RELEASE AND CONNECTION, BUT WITHOUT SUCCESS. ROSA USE DURING THE SURGERY WAS ABORTED, AND PROCEEDED WITH BRAINLAB INSTEAD. DELAY OF PROCEDURE NEARLY AN HOUR. ABLATION PROCEDURE." }, { "mdr_text_key": "202016432", "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": "202016453", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING SECOND ATTEMPT AT REGISTRATION, ROSA WAS PERFORMING AUTOMATIC SCANNING PORTION OF CONTACTLESS REGISTRATION. ARM DISCONNECTED, AND SHUTDOWN ERROR OCCURRED. ROBOT WAS SHUTDOWN AND THEN RESTARTED. ROBOT WAS UNABLE TO RECONNECT TO ARM, SO SHUTDOWN OCCURRED AGAIN. THE FIELD SERVICE ENGINEER (FSE) ATTEMPTED SEVERAL SHUTDOWNS, WITHOUT SUCCESS. ROBOT WAS REMOVED FROM PATIENT, AND MANUAL RELEASE WAS ATTEMPTED OUTSIDE OF OR. ARM WAS STILL UNABLE TO CONNECT. THE FSE CONTINUED TO PERFORM MANUAL RELEASE AND CONNECTION, BUT WITHOUT SUCCESS. ROSA USE DURING THE SURGERY WAS ABORTED, AND PROCEEDED WITH BRAINLAB INSTEAD. DELAY OF PROCEDURE NEARLY AN HOUR. ABLATION PROCEDURE." } ], "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": "11/25/2020" } ] }