{ "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": "3009185973-2019-00384", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20191106", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20191009", "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": "20191106", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1079790", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20191106", "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", "catalog_number": "N/A", "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": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/18/2019", "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": "20191106", "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": "20191220", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "9283675", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20191009", "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": "310508989", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FIELD SERVICE ENGINEER (FSE) REPORT A COMPLAINT THAT OCCURRED ON (B)(6) 2019 DURING AN SEEG SURGERY AT THE UNIVERSITY OF WISCONSIN (B)(4) AFTER REGISTRATION WAS PERFORMED, AN ERROR MESSAGE APPEARED THAT STATED THAT THE REGISTRATION COULD NOT BE COMPUTED. THE INITIAL POINTS WERE REDEFINED, BUT THE REGISTRATION STILL COULD NOT BE COMPUTED. THE REGISTRATION WAS THEREFORE CANCELLED AND RESTARTED. THE 3D RECONSTRUCTION WAS ADJUSTED PRIOR TO THE SECOND REGISTRATION AND THE SURGEON SPENT EXTRA ATTENTION ENSURING THE LASER DID NOT CROSS ANY HAIR AND WAS ORTHOGONAL TO THE SKIN. THIS CAUSE ABOUT A 35 MINUTE DELAY IN SURGERY. THERE WERE NO KNOWN ADVERSE EFFECTS TO THE PATIENT, AND THIS DID NOT INCLUDE A LONG TERM IMPLANT. SURGICAL PROTOCOL WAS FOLLOWED." }, { "mdr_text_key": "310508990", "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. ANALYSIS OF SOFTWARE LOGS CONCLUDED THAT THE COMPUTATION OF THE LASER REGISTRATION COULD NOT BE CORRECTLY COMPUTED TWICE DUE TO COARSE REGISTRATION ERRORS ON THE WHOLE CLOUD OF RECORDED POINTS. THIS ISSUE OCCURRED BECAUSE A STEP OF THE REGISTRATION WORKFLOW WAS NOT EXECUTED PROPERLY: THE ADJUSTMENT OF INITIAL POINTS COLLECTED. INDEED, EACH INITIAL POINT MODIFIED IN THE IMAGE MUST ALSO BE RE-COLLECTED WITH THE ROBOT, AS INDICATED IN THE USER MANUAL. ANALYSIS OF ROSANNA_BRAIN LOG FILE SHOWS THAT THIS CORRECT PRACTICE WAS NOT FOLLOWED, THEREFORE, THE ISSUE CAN BE CONSIDERED AS A USE ERROR." }, { "mdr_text_key": "165281504", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI#: (B)(4). 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": "165281505", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER (FSE) REPORT A COMPLAINT THAT OCCURRED ON (B)(6) 2019 DURING AN SEEG SURGERY AT THE (B)(6) (DEVICE BR18024). AFTER REGISTRATION WAS PERFORMED, AN ERROR MESSAGE APPEARED THAT STATED THAT THE REGISTRATION COULD NOT BE COMPUTED. THE INITIAL POINTS WERE REDEFINED, BUT THE REGISTRATION STILL COULD NOT BE COMPUTED. THE REGISTRATION WAS THEREFORE CANCELLED AND RESTARTED. THE 3D RECONSTRUCTION WAS ADJUSTED PRIOR TO THE SECOND REGISTRATION AND THE SURGEON SPENT EXTRA ATTENTION ENSURING THE LASER DID NOT CROSS ANY HAIR AND WAS ORTHOGONAL TO THE SKIN. THIS CAUSE ABOUT A 35 MINUTE DELAY IN SURGERY. THERE WERE NO KNOWN ADVERSE EFFECTS TO THE PATIENT, AND THIS DID NOT INCLUDE A LONG TERM IMPLANT. SURGICAL PROTOCOL WAS FOLLOWED." } ], "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": "12/23/2019" } ] }