{ "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": "3009185973-2020-00141", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200615", "manufacturer_address_2": "", "pma_pmn_number": "K182417", "date_of_event": "20200527", "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": "CA", "manufacturer_contact_area_code": "", "date_added": "20200615", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "619779", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200615", "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": "ROSAS00216", "lot_number": "3.1.1.1295", "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": [ "Display or Visual Feedback Problem", "Display or Visual Feedback Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/30/2020", "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": "20200615", "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": "20201022", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10152100", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20200526", "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": "320883392", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ANALYSIS HAS BEEN PERFORMED. THIS ANALYSIS CONCLUDED THAT THE ZOOMING BEHAVIOR THAT REPORTEDLY HAPPENED DURING THE VERIFICATION STEP WAS DUE TO THE FACT THAT THE \"LINK VIEWS\" BUTTON HAD BEEN INADVERTENTLY DESELECTED BY THE USER. WHEN THE \"LINK VIEWS\" BUTTON IS DESELECTED, THE VIEWS ARE NOT ZOOMED-IN AND CENTERED FOR EACH RECORDED POINT. THE DEFAULT ZOOM POSITIONING WAS DESIGNED WITH THE DEFAULT SETTINGS SELECTED. THE REPORTED EVENT IS A NORMAL BEHAVIOR OF THE DEVICE. NO ANOMALY WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY RESUMED AFTER A SYSTEM RESTART SINCE THE \"LINK VIEWS\" BUTTON IS SELECTED BY DEFAULT; THERE WAS NO CONSEQUENCE FOR THE PATIENT. CORRECTED DATA: B3 DATE OF EVENT . B4 DATE OF THIS REPORT. D4 LOT NUMBER. G4 DATE RECEIVED BY MANUFACTURER. H2 IF FOLLOW-UP, WHAT TYPE. H3 DEVICE EVALUATED BY MANUFACTURER. H6 EVENT PROBLEM AND EVALUATION CODES. H10 ADDITIONAL NARRATIVES/DATA." }, { "mdr_text_key": "320883393", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "CONTACTLESS REGISTRATION PERFORMED SUCCESSFULLY; DURING VERIFICATION STEP SURGEON MOVED LASER TO VERIFY SKIN MATCHING. SURGEON PUSHED \"RECORD\" , AND SOFTWARE DID NOT RESPOND CORRECTLY. SOFTWARE ONLY ZOOMED IN FOR ONE OF THE VIEWS AND IT WAS ZOOMED IN TOO FAR TO CORRECTLY VIEW AN VERIFY. SEVERAL ATTEMPTS WERE MADE, BUT SOFTWARE WAS NOT ZOOMING IN CORRECTLY. SURGEON ATTEMPTED TO MANUALLY ZOOM IN ALL VIEWS, BUT FOUND IT CHALLENGING. THE COMPANY FIELD SERVICE ENGINEER (FSE) SUGGESTED SURGEON SHUTDOWN AND RESTART SOFTWARE. DELAY OF PROCEDURE ROUGHLY 25 MINUTES. PATIENT UNDER ANESTHESIA, NO INCISION MADE, CASE PROCEEDED NORMALLY FOLLOWING RESTART. SEEG SURGERY, FSE PROVIDED REMOTE/ VIDEO SUPPORT." }, { "mdr_text_key": "196240879", "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. UNIQUE IDENTIFIER (UDI) (B)(4). (B)(4) WAS SELECTED AS THERE WAS A DELAY GREATER THAN 30 MINUTES ON THE SURGERY DUE TO THIS EVENT AND TO ANOTHER EVENT THAT OCCURRED DURING THE SAME SURGERY (3009185973-2020-00142)." }, { "mdr_text_key": "196240880", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CONTACTLESS REGISTRATION PERFORMED SUCCESSFULLY; DURING VERIFICATION STEP SURGEON MOVED LASER TO VERIFY SKIN MATCHING. SURGEON PUSHED \"RECORD\" , AND SOFTWARE DID NOT RESPOND CORRECTLY. SOFTWARE ONLY ZOOMED IN FOR ONE OF THE VIEWS AND IT WAS ZOOMED IN TOO FAR TO CORRECTLY VIEW AN VERIFY. SEVERAL ATTEMPTS WERE MADE, BUT SOFTWARE WAS NOT ZOOMING IN CORRECTLY. SURGEON ATTEMPTED TO MANUALLY ZOOM IN ALL VIEWS, BUT FOUND IT CHALLENGING. THE COMPANY FIELD SERVICE ENGINEER (FSE) SUGGESTED SURGEON SHUTDOWN AND RESTART SOFTWARE. DELAY OF PROCEDURE ROUGHLY 25 MINUTES. PATIENT UNDER ANESTHESIA, NO INCISION MADE, CASE PROCEEDED NORMALLY FOLLOWING RESTART. SEEG SURGERY, FSE PROVIDED REMOTE/ VIDEO SUPPORT." } ], "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": "10/23/2020" } ] }