{ "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": "3009185973-2019-00252", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190801", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190709", "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": "20190801", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "643288", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190801", "brand_name": "ROSA BRAIN", "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 BRAIN 3.0", "catalog_number": "ROSA BRAIN", "lot_number": "3.0.0.21", "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": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/16/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250801", "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": "20190801", "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": "20200114", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8850060", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190709", "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": "152907665", "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). 2 HOUR DELAY OCCURRED DUE TO THE REPEATED ATTEMPTS, FINALLY THE SURGEON CHOSE TO RESUME THE SURGERY WITHOUT USING ROSA BRAIN DEVICE. THIS IS CONSIDERED AS A SERIOUS INJURY." }, { "mdr_text_key": "152907666", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "REGISTRATION COMPLETED THREE TIMES BUT UNABLE TO ACHIEVE SUFFICIENT ACCURACY UPON VERIFICATION. SURGEON CHOSE TO ABORT PROCEDURE USING ROSA AND USED BRAINLAB INSTEAD. THE FIRST REGISTRATION WAS COMPLETED WITH SIGNIFICANT DIFFERENCES BETWEEN THE REFERENCE POINTS ON THE IMAGES AND THE POINTS COLLECTED DURING THE REGISTRATION. DURING VERIFICATION, IT WAS NOTED THAT THE MATCHING WAS NOT SATISFACTORY. SUFFICIENT ACCURACY ACCORDING TO THE SOFTWARE OCCURRED DURING THE SECOND ATTEMPT, AND THE SURFACE MATCHING SEEMED OK, BUT WHEN ATTEMPTING TO VERIFY THE INSULA TRAJECTORY, THE DISTANCE SENSOR WAS > 2 MM FROM SURFACE OF SCALP. REGISTRATION WAS THEN REPEATED FOR A THIRD TIME. FOR THIS ATTEMPT, THE 3D RECONSTRUCTION WAS ADJUSTED ALONG WITH THE CONTRAST, AND THE SURGEON MADE SURE TO BE MORE ORTHOGONAL TOWARDS SURFACE OF SKIN. AGAIN, THIS WAS INSUFFICIENT, AND ANOTHER ATTEMPT WAS MADE TO REGISTER THE PATIENT WITH ADDITIONAL 3D RECONSTRUCTION MODIFICATIONS MADE TO REMOVE ANY ARTIFACT OR HAIR ON THE RECONSTRUCTION. 2 HOUR DELAY OCCURRED DUE TO THE REPEATED REGISTRATION ATTEMPTS. SURGERY WAS TO BE SEEG WITH GRIDS AND STRIPS. FULL ACCURACY, APPLICATIVE AND PREVENTATIVE MAINTENANCE WERE PERFORMED." }, { "mdr_text_key": "315175173", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DESPITE MULTIPLE ATTEMPTS THE USER WAS UNABLE TO ACHIEVE A SUFFICIENT REGISTRATION ACCURACY UPON VERIFICATION. EVENT SUMMARY, DEVICE HISTORY RECORD REVIEW AND COMPLAINT HISTORY REVIEW DID NOT IDENTIFY CONTRIBUTING FACTORS. THE TECHNICAL INVESTIGATION CONFIRMED THAT IT WAS LIKELY DUE TO THE DISTANCE SENSOR ACCURACY WHICH WAS REDUCED BY THE STERILE INTERFACE NOT BEING SUFFICIENTLY TIGHTENED. THE REGISTRATION VERIFICATIONS WERE PERFORMED PROPERLY AND THE USER HAD THE CORRECT ATTITUDE WHEN CANCELLING THE REGISTRATIONS. HOWEVER IT WAS NOTED THAT THE USER CORRECTED THE INITIAL POINTS ON THE 3D MODEL WITHOUT RE-COLLECTING THEM WITH THE ROBOT ARM ON THE PATIENT¿S FACE. IT CAN ALSO BE A FACTOR OF THE REGISTRATION INACCURACY." }, { "mdr_text_key": "315175174", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REGISTRATION COMPLETED THREE TIMES BUT UNABLE TO ACHIEVE SUFFICIENT ACCURACY UPON VERIFICATION. SURGEON CHOSE TO ABORT PROCEDURE USING ROSA AND USED BRAINLAB INSTEAD. THE FIRST REGISTRATION WAS COMPLETED WITH SIGNIFICANT DIFFERENCES BETWEEN THE REFERENCE POINTS ON THE IMAGES AND THE POINTS COLLECTED DURING THE REGISTRATION. DURING VERIFICATION, IT WAS NOTED THAT THE MATCHING WAS NOT SATISFACTORY. SUFFICIENT ACCURACY ACCORDING TO THE SOFTWARE OCCURRED DURING THE SECOND ATTEMPT, AND THE SURFACE MATCHING SEEMED OK, BUT WHEN ATTEMPTING TO VERIFY THE INSULA TRAJECTORY, THE DISTANCE SENSOR WAS > 2 MM FROM SURFACE OF SCALP. REGISTRATION WAS THEN REPEATED FOR A THIRD TIME. FOR THIS ATTEMPT, THE 3D RECONSTRUCTION WAS ADJUSTED ALONG WITH THE CONTRAST, AND THE SURGEON MADE SURE TO BE MORE ORTHOGONAL TOWARDS SURFACE OF SKIN. AGAIN, THIS WAS INSUFFICIENT, AND ANOTHER ATTEMPT WAS MADE TO REGISTER THE PATIENT WITH ADDITIONAL 3D RECONSTRUCTION MODIFICATIONS MADE TO REMOVE ANY ARTIFACT OR HAIR ON THE RECONSTRUCTION. 2 HOUR DELAY OCCURRED DUE TO THE REPEATED REGISTRATION ATTEMPTS. SURGERY WAS TO BE SEEG WITH GRIDS AND STRIPS. FULL ACCURACY, APPLICATIVE AND PREVENTATIVE MAINTENANCE WERE PERFORMED." } ], "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": "01/15/2020" } ] }