{ "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": "2955842-2025-45524", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251121", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20250407", "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", "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20251121", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "906261", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251121", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "380652", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251121", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "57 YR", "patient_sex": "Female", "patient_weight": "43 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumonia", "Cardiovascular Dysfunction/Insufficiency", "Kidney injury", "Pneumonia", "Cardiovascular Dysfunction/Insufficiency", "Kidney injury" ] } ], "distributor_city": "", "date_report": "20251121", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23617460", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251031", "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": "385753753", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. IN SECTION B3, THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 31-OCT-2025. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC XI SYSTEM WAS REPORTED. CITATION: CHANG, STEPHANIE H. ET AL. (2025). INITIAL EXPERIENCE WITH FULLY ROBOTIC BILATERAL LUNG TRANSPLANTATION. THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, VOLUME 170, ISSUE 4, E87 - E91. HTTPS://DOI.ORG/10.1016/J.JTCVS.2025.04.011." }, { "mdr_text_key": "385753754", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE, \"INITIAL EXPERIENCE WITH FULLY ROBOTIC BILATERAL LUNG TRANSPLANTATION\" WAS PERFORMED. THE DA VINCI XI SURGICAL SYSTEM WAS USED DURING THE SURGERY. THE ARTICLE NOTED THAT ONE PATIENT, A 57-YEAR-OLD WOMAN WITH A HISTORY OF END-STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DEVELOPED ATRIAL FIBRILLATION, ACUTE KIDNEY INJURY, PROLONGED AIR LEAK, AND PNEUMONIA (DONOR) AFTER THE PROCEDURE. THE AUTHORS CONCLUDED THAT INTRAOPERATIVELY, THERE WAS DECREASED CARDIAC DYSFUNCTION DURING HILAR EXPOSURE WITH DECREASED HEMODYNAMIC SHIFTS, AND LESS PAIN REPORTED BY THE PATIENT. THERE WAS ALSO AN INCREASED TOTAL ISCHEMIC TIME, WARM ISCHEMIC TIME, AND OVERALL OPERATIVE TIME. IT WAS DETERMINED THAT ROBOTIC TRANSPLANTATION AND FUTURE COMPARATIVE STUDIES WITH LARGER PATIENT COHORTS ARE NEEDED TO ASSESS THE TRUE RISKS AND BENEFITS OF ROBOTIC LUNG TRANSPLANTATION. PER THE AUTHOR, THE COMPLICATION HAD NOTHING TO DO WITH THE DA VINCI DEVICE. THERE WERE NO SPECIFIC 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": "" } ] }