{ "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": "3009185973-2020-00127", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200526", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "BIOMEDICAL ENGINEER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "551071", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200526", "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": "0", "model_number": "ROSA ONE", "catalog_number": "ROSAS00203", "lot_number": "3.1.1.1295", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "HAW", "device_age_text": "", "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": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20200526", "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": "20200525", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10085996", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200514", "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": "194809501", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. THE CT LOADING FAILED FROM THE USB BECAUSE SERIES WAS EXPORTED ON USB WITH A COMPRESSED FORMAT. YET, COMPRESSED IMAGES CANNOT BE READ INTO ROSA ONE BRAIN SOFTWARE. THE DEVICE BEHAVED AS EXPECTED. THE ACQUISITION PROTOCOL PROVIDES RECOMMENDATION TO PERMIT A CORRECT READING OF DATA IN THE SOFTWARE. THEREFORE THIS EVENT IS CONSIDERED AS A USE ERROR. (B)(4)." }, { "mdr_text_key": "194809502", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "A FIELD SERVICE ENGINEER (FES) SUPPORTED AN SEEG CASE AT SPECTRUM HEALTH FOR DR. (B)(6) ON (B)(6) 2020 USING DEVICE S/N (B)(4). THE ORIGINAL CT SCAN THAT HAD BEEN TAKEN FOR SURGERY WAS DETERMINED TO BE UNUSABLE SINCE THE PATIENT HAD A MASK ON DURING THE SCAN. THE MASK COULD HAVE MADE THE LASER REGISTRATION INACCURATE, SO THE SURGEON DECIDED TO GET ANOTHER CT SCAN THAT MORNING BEFORE THE CASE. THE NEW CT IMAGING WAS PLACED ON A USB, AND IT WAS ATTEMPTED TO BE UPLOADED THROUGH THE ROSA SOFTWARE GOING THROUGH THE 'USB' PATHWAY. WHEN THE IMAGING WAS SELECTED, THE RESOLUTION APPEARED TO BE 0X0. THE FSE ATTEMPTED TO LOOK AT THE DICOM HEADINGS TO SEE IF THERE WAS ANYTHING THAT STOOD OUT, BUT NOTHING APPEARED TO BE AN ISSUE. THE FSE ATTEMPTED TO CONTACT RADIOLOGY AT THE HOSPITAL, BUT WAS UNABLE TO GET THE SUPPORT NEEDED. AFTER ABOUT A 45 MINUTE DELAY, THE FSE THEN ATTEMPTED TO GO THROUGH IQ-VIEW AND SELECT THE IMAGING GOING THROUGH THAT DIFFERENT PATHWAY. WHEN THE IMAGING WAS SELECTED AND UPLOADED THROUGH IQ-VIEW, THE CT IMAGING APPEARED ON THE ROSA SOFTWARE AND THE RESOLUTION WAS NO LONGER 0X0 AND COULD CORRECTLY BE UPLOADED AND MERGED. THERE WERE NO OTHER ISSUES EXPERIENCED AFTER THAT POINT. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISIONS WERE MADE YET. THE TOTAL DELAY FOR THIS ISSUE WAS AROUND 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": "" } ] }