{ "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": "3009185973-2021-00147", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210602", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20210407", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20210602", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "816369", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20210602", "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": "3.1.4.1650", "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 Application Program Shut Down", "Unintended Application Program Shut Down" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/04/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20210602", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20211008", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11918762", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210507", "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": "326702569", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A USER REPORTED BY PHONE THAT DURING A SURGERY 'BRAIN BIOPSY', AT THE TIME OF THE REGISTRATION THE ROBOT DISPLAYED AN 'ERROR MESSAGE SIGNALING A SHUTDOWN'. THE ROBOT SHUT DOWN AND RESTARTED. OBLIGATION FOR THE SURGEON TO RE-SET UP PATIENT INFORMATION: THIS SITUATION HAS OCCURRED TWICE. THIS SITUATION CAUSES AN IMPACT FOR THE PATIENT BY A LONGER ANESTHESIA DURATION, A LONGER PROCEDURE" }, { "mdr_text_key": "326702570", "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 PERMITTED TO CONCLUDE THAT THE ARM CONNECTION FAILED DUE TO A MEMORY ALLOCATION ISSUE THAT PREVENTED ITS COMPLETE INITIALIZATION. CONSEQUENTLY, THE SOFTWARE ASKED TO RESTART THE APPLICATION OR SHUT DOWN THE COMPUTER. IN ORDER TO SOLVE THE ISSUE, THE USER HAD TO SHUT DOWN AND REBOOT THE COMPUTER. THIS ISSUE WAS ALREADY ADDRESSED THROUGH THE CONTINUOUS IMPROVEMENT PROCESS OF OUR PRODUCTS." }, { "mdr_text_key": "253683016", "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)." }, { "mdr_text_key": "253683017", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A USER REPORTED BY PHONE THAT DURING A SURGERY 'BRAIN BIOPSY', AT THE TIME OF THE REACYLATION THE ROBOT DISPLAYED AN 'ERROR MESSAGE SIGNALING A SHUTDOWN'. THE ROBOT WENT OUT AND RELAUNCHED ITSELF. OBLIGATION FOR THE SURGEON TO RE-SET UP PATIENT INFORMATION: THIS SITUATION HAS OCCURRED TWICE. THIS SITUATION CAUSES AN IMPACT FOR THE PATIENT BY A LONGER ANESTHESIA DURATION, A LONGER 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": "10/08/2021" } ] }