{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2025-01663", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250220", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20221001", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250220", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2554533", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250220", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20250220", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "73 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cerebrospinal Fluid Leakage", "Cerebrospinal Fluid Leakage" ] } ], "distributor_city": "", "date_report": "20250127", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21425214", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250127", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "364074212", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: YUNZE LI, HAIBO HUANG, MEDIASTINAL SCHWANNOMA COMPLICATED WITH CEREBROSPINAL FLUID LEAKAGE AFTER DA VINCI ROBOT TREATMENT: ONE CASE REPORT, CHINESE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, VOLUME 40, NUMBER 7, JULY 2024 DOI: 10.3760/CMA.J.CN112434-20240117-00013. THE ONLY EVENT DATE MENTIONED IN THE ARTICLE WAS OCTOBER2022. THE EXACT DATE WAS NOT IDENTIFIED. THEREFORE, A DATE OF 01-OCT-2022 WAS USED AS THE EVENT DATE. REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE; NO RESPONSE HAS BEEN RECEIVED. IN SECTION D THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURE WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE." }, { "mdr_text_key": "364074213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A CASE STUDY OF A 73-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED ROBOTIC POSTERIOR MEDIASTINAL MASS RESECTION ON THE LEFT CHEST. A CHEST DRAINAGE TUBE WAS PLACED. MAGNETIC RESONANCE IMAGING (MRI) OF THE THORACIC SPINE SHOWED A POST-OPERATIVE ABNORMAL SIGNAL AND A LEFT PARAMASS OF THE 10TH THORAX VERTEBRAE. CEREBROSPINAL FLUID LEAKAGE OCCURRED AFTER SURGERY DUE TO THE CLOSE RELATIONSHIP BETWEEN THE MEDIASTINAL MASS AND THE INTERVERTEBRAL FORAMINA, RESULTING IN A DURAL TEAR. BEDREST WAS ORDERED. MRIS WERE REPEATED AT ONE AND TWO WEEKS AFTER THE SURGERY. THE ABNORMAL SIGNAL WAS SMALLER THAN BEFORE. THE CHEST DRAIN WAS REMOVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 15 DAYS AFTER SURGERY. THE PATIENT REMAINED ON BEDREST FOR TWO WEEKS AFTER DISCHARGE. THE EVENT WAS REPORTED AS CURED AFTER THREE WEEKS OF BEDRIDDEN TREATMENT. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }