{ "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": "3009185973-2018-00262", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20181005", "manufacturer_address_2": "", "pma_pmn_number": "PN/A", "date_of_event": "20180927", "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": "GM", "manufacturer_contact_area_code": "", "date_added": "20181005", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "780781", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20181005", "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": "N/A", "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": [ "Imprecision", "Insufficient Device Problem Information", "Imprecision", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/28/2018", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20181005", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage, Cerebral", "Hemorrhage, Cerebral" ] } ], "distributor_city": "", "date_report": "20181218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7938419", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20180927", "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": "310463126", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE SURGEON REGISTERED THE PATIENT FIRST WITH THE LASER REGISTRATION. THE SURGEON ONLY CHECKED ONE POINT WITH THE LASER. THEN HE DECIDED TO CHANGE TO ANOTHER FORM OF REGISTRATION, AND USED THE POINTER AND CHECKED THE SKIN FIDUCIALS AS LANDMARKS. THE SKIN FIDUCIALS DID NOT FIT WITH THE PLANNING. THE SURGEON REGISTERED THE SKIN FIDUCIALS. THE SKIN FIDUCIAL REGISTRATION WAS NOT ADEQUATE (> 3MM RMS). THE SURGEON THEN PERFORMED ANOTHER LASER REGISTRATION. THE ROBOT DISPLAYED A WARNING MESSAGE. THE FIELD SERVICE TECHNICIAN LATER CHECKED THE DATA LOGS AND CONFIRMED THAT THE RMS WAS TOO HIGH. THE SURGEON CHECKED 3 POINTS AND THE THIRD POINT DID NOT MATCH. HE REGISTERED AGAIN WITH THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION, BUT WAS NOT SATISFIED WITH THE REGISTRATION. HE REGISTERED THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION AND DECIDED TO PROCEED WITH THE SURGERY. WHEN HE TOOK THE SECOND PROBE, BLOOD CAME OUT OF THE NEEDLE. HE WAS ABLE TO STOP THE BLEEDING BY FLUSHING THROUGH THE BIOPSY NEEDLE. THE POST-OPERATIVE CT SHOWED SOME BLOOD STILL. ON THE CT, IT WAS NOT POSSIBLE TO CHECK THE ACCURACY OF THE TRAJECTORY." }, { "mdr_text_key": "310463127", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A SURGERY, THE SURGEON HAD DIFFICULTIES TO PERFORM THE LASER REGISTRATION AND A HAEMORRHAGE OCCURRED. DHR REVIEW DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. REVIEW OF COMPLAINT HISTORY SHOWED THAT FOUR COMPLAINTS WERE ALREADY RECEIVED FOR LASER REGISTRATION ISSUES FOR THIS DEVICE.THE ACCURACY OF THE TRAJECTORY WAS MEASURED AT THE ENTRY POINT AS A REFERENCE FOR THE BIOPSY NEEDLE ENTRANCE. THE INACCURACY IS CONFIRMED AND IS DUE TO THE BAD REGISTRATION PERFORMED BEFORE THE BEGINNING OF SURGERY. THE SURGEON FACED DIFFICULTIES TO PERFORM THE REGISTRATION. BOTH LASER AND MARKER REGISTRATIONS WERE ATTEMPTED. THE FINAL MARKER REGISTRATION WAS VALIDATED WITH ERRORS ON THE RMS ERROR AND IN VERIFICATION STEP BUT THE USER DECIDED TO RESUME THE CASE DESPITE THE WARNING MESSAGES. THE IFU PROVIDES THE NECESSARY INFORMATION TO AVOID ACCURACY ISSUES RELATED TO SKIN FIDUCIALS REGISTRATION. THE HEMORRHAGE WAS DUE TO AN INACCURACY OF THE DEVICE DUE TO THE ACCEPTANCE OF A BAD REGISTRATION. THIS IS A USER ERROR. CORRECTED DATA: DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. IF FOLLOW-UP, WHAT TYPE. DEVICE EVALUATED BY MANUFACTURER. EVALUATION CODE." }, { "mdr_text_key": "122856174", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION WILL BE PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THE DEVICE MODEL ROSA ONE IS NOT FDA CLEARED BUT IS SIMILAR TO THE DEVICE ROSA BRAIN 3.0, CLASSIFIED HAW AND CLEARED UNDER K172444." }, { "mdr_text_key": "122856175", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE SURGEON REGISTERED THE PATIENT FIRST WITH THE LASER REGISTRATION. THE SURGEON ONLY CHECKED ONE POINT WITH THE LASER. THEN HE DECIDED TO CHANGE TO ANOTHER FORM OF REGISTRATION, AND USED THE POINTER AND CHECKED THE SKIN FIDUCIALS AS LANDMARKS. THE SKIN FIDUCIALS DID NOT FIT WITH THE PLANNING. THE SURGEON REGISTERED THE SKIN FIDUCIALS. THE SKIN FIDUCIAL REGISTRATION WAS NOT ADEQUATE (> 3MM RMS). THE SURGEON THEN PERFORMED ANOTHER LASER REGISTRATION. THE ROBOT DISPLAYED A WARNING MESSAGE. THE FIELD SERVICE TECHNICIAN LATER CHECKED THE DATA LOGS AND CONFIRMED THAT THE RMS WAS TOO HIGH. THE SURGEON CHECKED 3 POINTS AND THE THIRD POINT DID NOT MATCH. HE REGISTERED AGAIN WITH THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION, BUT WAS NOT SATISFIED WITH THE REGISTRATION. HE REGISTERED THE SKIN FIDUCIALS AND CHECKED THE REGISTRATION AND DECIDED TO PROCEED WITH THE SURGERY. WHEN HE TOOK THE SECOND PROBE, BLOOD CAME OUT OF THE NEEDLE. HE WAS ABLE TO STOP THE BLEEDING BY FLUSHING THROUGH THE BIOPSY NEEDLE. THE POST-OPERATIVE CT SHOWED SOME BLOOD STILL. ON THE CT, IT WAS NOT POSSIBLE TO CHECK THE ACCURACY OF THE TRAJECTORY." } ], "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": "12/18/2018" } ] }