{ "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": "2955842-2025-35176", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250825", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250217", "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", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250825", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2678391", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250825", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "UNKNOWN", "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": "20250926", "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": "20250825", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Asian", "patient_problems": [ "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20250729", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22884249", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250729", "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": "378444824", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE TITLED, \"LOBECTOMY FOR PRIMARY LUNG CANCER: A COMPARISON OF PERIOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN ROBOT-ASSISTED THORACIC SURGERY AND VIDEO-ASSISTED THORACIC SURGERY,\" (VATS) WAS PERFORMED. THE ARTICLE DISCUSSED A RETROSPECTIVE COHORT STUDY THAT INCLUDED MALE PATIENTS WHO UNDERWENT ROBOT-ASSISTED THORACIC SURGERY (RATS) OR VATS AT A SINGLE CENTER BETWEEN APRIL 2018 AND MARCH 2022. A TOTAL OF 137 PATIENT WERE INCLUDED IN EACH GROUP, RATS AND VATS. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THE INCIDENCE OF PROLONGED POSTOPERATIVE AIR LEAK WAS SIGNIFICANTLY HIGHER IN THE RATS GROUP THAN IN THE VATS GROUP. THERE WERE 13 POSTOPERATIVE AIR LEAKS IN THE RATS GROUP VERSUS 3 IN THE VATS GROUP, RESULTING IN A SIGNIFICANTLY LONGER DURATION OF CHEST TUBE PLACEMENT IN THE RATS GROUP. THE ARTICLE ALSO STATED THAT PULMONARY ARTERY INJURIES ACCOUNTED FOR HALF OF THE INTRAOPERATIVE INJURIES IN THE RATS GROUP AND THAT THE SINGLE CONVERSION TO THORACOTOMY WAS DUE TO PULMONARY ARTERY INJURY. PER THE AUTHOR, THE INJURIES WERE NOT DUE TO THE DA VINCI SYSTEM OR THE INSTRUMENTS, BUT DUE TO THE RATS PROCEDURE AND THAT THE VESSELS WERE SUSCEPTIBLE TO DAMAGE DUE TO INFILTRATION AND LYMPH NODES, ETC. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS OR DEATHS REPORTED AND THAT NO INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. THE CONCLUSION WAS THAT IN LOBECTOMIES FOR LUNG CANCER, RATS DEMONSTRATED LONG-TERM OUTCOMES THAT WERE COMPARABLE TO THOSE OF VATS. ALTHOUGH RATS HAS A LONGER OPERATIVE TIME, IT IS ASSOCIATED WITH LESS BLOOD LOSS AND A LOWER CONVERSION RATE TO OPEN THORACOTOMY THAN VATS, SUGGESTING THAT IT IS A FAVORABLE SURGICAL APPROACH FOR PATIENTS." }, { "mdr_text_key": "378444825", "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. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. CITATION: UENO, H., ET AL. (2025). LOBECTOMY FOR PRIMARY LUNG CANCER: A COMPARISON OF PERIOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN ROBOT-ASSISTED THORACIC SURGERY AND VIDEO-ASSISTED THORACIC SURGERY. SURGERY TODAY. HTTPS://DOI.ORG/10.1007/S00595-025-03000-6." } ], "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": "" } ] }