{ "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": "2955842-2024-22537", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241204", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240426", "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", "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": "20241205", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1871721", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241204", "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": "UNKNOWN", "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": "FL", "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": "20241204", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Hemorrhage/Blood Loss/Bleeding", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20241106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20850146", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241106", "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": "358328124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION: MAREK JC, DUMITRIU CARCOANA AO, WEST WJ, ET AL., MARITAL STATUS SHOWS NO PROTECTIVE EFFECT ON PERIOPERATIVE OUTCOMES AFTER ROBOTIC-ASSISTED PULMONARY LOBECTOMY, SURGERY IN PRACTICE AND SCIENCE, VOLUME 18, 2024, 100250, ISSN 2666-2620 HTTPS://DOI.ORG/10.1016/J.SIPAS.2024.100250. SECTION D - SUSPECT DEVICE: THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE. ." }, { "mdr_text_key": "358328125", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED ANALYSIS OF A RETROSPECTIVE COHORT STUDY INVESTIGATING THE IMPACT OF MARITAL STATUS ON PERIOPERATIVE OUTCOMES IN PATIENTS UNDERGOING ROBOTIC-ASSISTED PULMONARY LOBECTOMY (RAPL) FOR NON-SMALL CELL LUNG CANCER (NSCLC). THE STUDY OCCURRED FROM SEPTEMBER 2010 TO MARCH 2022, DURING WHICH 709 PATIENTS UNDERWENT RAPL. OF THE 709 SURGERIES, IT WAS REPORTED THAT THERE WERE 40 INTRAOPERATIVE COMPLICATIONS, 32 OF WHICH WERE ROBOTIC-ASSOCIATED INTRAOPERATIVE COMPLICATIONS. THE COMPLICATIONS INCLUDED PULMONARY ARTERY BLEEDING, PULMONARY VEIN BLEEDING, \"OTHER\" BLEEDING, TRACHEAL/BRONCHIAL INJURIES, A DIAPHRAGM INJURY, AND A PHRENIC NERVE INJURY. PERIOPERATIVE OUTCOMES INCLUDED AT TOTAL OF 39 OVERALL CONVERSIONS TO THORACOTOMY, 15 OF WHICH WERE URGENT CONVERSIONS. IN-HOSPITAL MORTALITY RATES WERE LOW IN BOTH GROUPS. THE DESIGNATED AUTHOR HAS CONFIRMED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, AND THAT NO DA VINCI DEVICES CAUSED OR CONTRIBUTED TO ANY OF THE REPORTED COMPLICATIONS." } ], "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": "" } ] }