{ "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": "3009185973-2020-00259", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201012", "manufacturer_address_2": "", "pma_pmn_number": "K200511", "date_of_event": "20201006", "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": "20201012", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1127544", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201012", "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": "ROSAS00203", "lot_number": "3.1.4.1650", "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": [ "Patient Data Problem", "Patient Data Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "11/16/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20201012", "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": "20201117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10660844", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201006", "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": "321663536", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND REVEALED THAT THE IMAGING COULD NOT BE RETRIEVED FROM THE PACS BECAUSE THE TEMPORARY IQ-VIEW FOLDER COULD NOT BE CLEARED. THE REPORTED ROSA SOFTWARE FREEZE WAS ALSO CONFIRMED. THESE ISSUES RESULT FROM KNOWN SOFTWARE ANOMALIES.THERE WAS NO IMPACT ON THE PATIENT / PROCEDURE OTHER THAN THE DELAY." }, { "mdr_text_key": "321663537", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPANY CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION CASE ON (B)(6) 2020 USING BS17937. AROUND 8:22AM EST, THE CR ATTEMPTED TO RETRIEVE IMAGING THROUGH PACS, BUT THIS FAILED AND THE SOFTWARE NEEDED TO BE RESTARTED. THE CR WAS ABLE TO QUERY IMAGING, BUT NOT RETRIEVE. THE IQ-VIEW SOFTWARE APPEARED TO ALLOW THE RETRIEVAL RANDOMLY BUT THERE WAS NO REASON OR PATTERN FOR WHEN IT WOULD AND WOULD NOT WORK CORRECTLY. THE SURGEON DECIDED TO GIVE UP ON PACS RETRIEVAL AND OBTAINED A CD WITH PATIENT IMAGING. AROUND 9:40AM EST, THE CD WAS LOADED INTO THE SOFTWARE TO LOAD THE PATIENT IMAGING. THE SURGEON WOULD LIKE TO ESCALATE THIS ISSUE SINCE THE PACS RETRIEVAL APPEARS TO WORK BUT WILL RANDOMLY NOT WORK. THE CR CONFIRMED WITH PACS/IT THAT ALL INFO IS CORRECT FOR PACS NETWORK. SINCE QUERY/RETRIEVE DOES WORK SOMETIMES, THAT MEANS THE INFO IS CORRECT ON BOTH THE ROBOT SIDE AND PACS SIDE. MOST LIKELY THERE IS AN ISSUE WITH THE IQ-VIEW SOFTWARE AND THE BRAIN SOFTWARE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISION MADE. THE DELAY WAS AROUND AN HOUR SINCE PACS WAS BEING RELIED ON FOR PATIENT IMAGING." }, { "mdr_text_key": "211324799", "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. (B)(4)." }, { "mdr_text_key": "211324800", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE COMPANY CLINICAL REPRESENTATIVE (CR) ASSISTED THE SURGEON FOR AN ABLATION CASE ON (B)(6) 2020 USING BS17937. AROUND 8:22AM EST, THE CR ATTEMPTED TO RETRIEVE IMAGING THROUGH PACS, BUT THIS FAILED AND THE SOFTWARE NEEDED TO BE RESTARTED. THE CR WAS ABLE TO QUERY IMAGING, BUT NOT RETRIEVE. THE IQ-VIEW SOFTWARE APPEARED TO ALLOW THE RETRIEVAL RANDOMLY BUT THERE WAS NO REASON OR PATTERN FOR WHEN IT WOULD AND WOULD NOT WORK CORRECTLY. THE SURGEON DECIDED TO GIVE UP ON PACS RETRIEVAL AND OBTAINED A CD WITH PATIENT IMAGING. AROUND 9:40AM EST, THE CD WAS LOADED INTO THE SOFTWARE TO LOAD THE PATIENT IMAGING. THE SURGEON WOULD LIKE TO ESCALATE THIS ISSUE SINCE THE PACS RETRIEVAL APPEARS TO WORK BUT WILL RANDOMLY NOT WORK. THE CR CONFIRMED WITH PACS/IT THAT ALL INFO IS CORRECT FOR PACS NETWORK. SINCE QUERY/RETRIEVE DOES WORK SOMETIMES, THAT MEANS THE INFO IS CORRECT ON BOTH THE ROBOT SIDE AND PACS SIDE. MOST LIKELY THERE IS AN ISSUE WITH THE IQ-VIEW SOFTWARE AND THE BRAIN SOFTWARE. THE PATIENT WAS UNDER ANESTHESIA AND NO INCISION MADE. THE DELAY WAS AROUND AN HOUR SINCE PACS WAS BEING RELIED ON FOR PATIENT IMAGING." } ], "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": "11/17/2020" } ] }