{ "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": "3009185973-2019-00096", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20190321", "manufacturer_address_2": "", "pma_pmn_number": "K172444", "date_of_event": "20190221", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20190321", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "234612", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190321", "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/15/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20190321", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20190513", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8440368", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20190221", "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": "312102673", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE LASER REGISTRATION WAS NOT ACCURATE. DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. ACCORDING TO TECHNICAL INVESTIGATION THE MANUAL AND/OR AUTOMATIC SCANS MADE OF THE HEAD OF THE PATIENT WERE INCORRECTLY PERFORMED. THE USER MANUAL WARNS THE USER TO CHECK INITIAL POINTS AND AUTOMATIC SCAN. THE ROOT CAUSE OF THIS EVENT IS A USE ERROR, IFU WAS NOT FOLLOWED. THE SURGEON IS CONSIDERED AS AN EXPERIENCED USER OF THE DEVICE." }, { "mdr_text_key": "312102674", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ROSA SOFTWARE INDICATED LASER REGISTRATION WAS INSUFFICIENTLY ACCURATE. SURGEON PROCEEDED TO VERIFICATION STAGE BUT WAS NOT SATISFIED WITH ACCURACY AT SEVERAL POINTS. SURGEON RE-STARTED REGISTRATION BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS RE-POSITIONED PATIENT TO BE LOWER TOWARD THE FLOOR AND RE-STARTED REGISTRATION, BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS DETERMINED ACCURACY WAS SUFFICIENTLY ACCURATE IN VERIFICATION STAGE FOR THE PURPOSE OF LASER ABLATION, AND PROCEEDED WITH SURGERY. POST-OPERATIVE MRI INDICATES LASER CATHETER PLACEMENT WAS SUFFICIENTLY ACCURATE. SURGEON BELIEVES REGISTRATION PROBLEMS MAY HAVE BEEN DUE TO SWELLING FROM PRIOR PLACEMENT OF HEAD HOLDER PIN NEAR THE CENTER OF THE FOREHEAD. PATIENT WAS ANESTHETIZED, FIRST INCISION WAS MADE, ESTIMATED TIME LOST WAS 45 MINUTES." }, { "mdr_text_key": "139462335", "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." }, { "mdr_text_key": "139462336", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "(B)(4) SOFTWARE INDICATED LASER REGISTRATION WAS INSUFFICIENTLY ACCURATE. SURGEON PROCEEDED TO VERIFICATION STAGE BUT WAS NOT SATISFIED WITH ACCURACY AT SEVERAL POINTS. SURGEON RE-STARTED REGISTRATION BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS RE-POSITIONED PATIENT TO BE LOWER TOWARD THE FLOOR AND RE-STARTED REGISTRATION, BUT RESULTS WERE AGAIN INSUFFICIENTLY ACCURATE. SURGEONS DETERMINED ACCURACY WAS SUFFICIENTLY ACCURATE IN VERIFICATION STAGE FOR THE PURPOSE OF LASER ABLATION, AND PROCEEDED WITH SURGERY. POST-OPERATIVE MRI INDICATES LASER CATHETER PLACEMENT WAS SUFFICIENTLY ACCURATE. SURGEON BELIEVES REGISTRATION PROBLEMS MAY HAVE BEEN DUE TO SWELLING FROM PRIOR PLACEMENT OF HEAD HOLDER PIN NEAR THE CENTER OF THE FOREHEAD. PATIENT WAS ANESTHETIZED, FIRST INCISION WAS MADE, ESTIMATED TIME LOST WAS 45 MINUTES." } ], "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": "05/13/2019" } ] }