{ "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": "2955842-2022-11002", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220410", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20220410", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1299922", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220410", "brand_name": "DA VINCI S/SI", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380430-03", "catalog_number": "380430", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": "", "date_changed": "20250801", "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": "20220410", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Atrial Fibrillation", "Fistula", "Pneumonia", "Atrial Fibrillation", "Fistula", "Pneumonia" ] } ], "distributor_city": "", "date_report": "20220311", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14069342", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220311", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "293696970", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 11-MAR-2022, INTUITIVE BECAME AWARE OF A \"TRANSLATIONAL LUNG CANCER RESEARCH\" JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED THORACIC SURGERY REDUCES PERIOPERATIVE COMPLICATIONS AND ACHIEVES A SIMILAR LONG-TERM SURVIVAL PROFILE AS POSTEROLATERAL THORACOTOMY IN CLINICAL N2 STAGE NON-SMALL CELL LUNG CANCER PATIENTS: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL¿ (HUANG, J., TIAN, Y., ET AL., 2021). THIS STUDY WAS DONE TO EXPLORE THE LONG-TERM EFFICACY AND POTENTIAL BENEFIT IN SURVIVAL OF ROBOTIC-ASSISTED THORACIC SURGERY (RATS) COMPARED WITH LOBECTOMY IN CLINICAL N2 (C-N2) STAGE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI SURGICAL PROCEDURES WERE NOTED: POSTOPERATIVE COMPLICATIONS THAT OCCURRED IN THE RATS GROUP WERE PROLONGED AIR LEAK (7.9%) AND BRONCHOPLEURAL FISTULA. ADDITIONALLY, THE FOLLOWING COMPLICATIONS WERE OBSERVED AMONG THE PATIENTS IN THE RATS GROUP: 3 PATIENTS EXPERIENCED PNEUMONIA, 3 PATIENTS HAD ATRIAL FIBRILLATION, 3 PATIENTS HAD ATRIAL ARRHYTHMIA, 3 PATIENTS UNDERWENT CHEST TUBE INSERTION, 3 PATIENTS EXPERIENCED SUBCUTANEOUS EMPHYSEMA, 3 PATIENTS HAD CHYLOTHORAX, 2 PATIENTS EXPERIENCED HYPERPYREXIA, 2 PATIENTS EXPERIENCED HEMORRHAGE, 1 PATIENT HAD RECURRENT LARYNGEAL NERVE INJURY, AND 1 PATIENT EXPERIENCED PULMONARY EMBOLISM. THE AUTHORS NOTED THAT THE COMPLICATIONS WERE MILD AND MANAGEABLE AND, \"OVERALL, PATIENTS UNDERGOING RATS HAD LESS SURGICAL INJURY AND BETTER RECOVERY DURING HOSPITALIZATION WITHOUT INCREASING THE POSTOPERATIVE COMPLICATIONS.\" ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET A RESPONSE." }, { "mdr_text_key": "293696971", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE REPORTED COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC-ASSISTED THORACIC SURGERY REDUCES PERIOPERATIVE COMPLICATIONS AND ACHIEVES A SIMILAR LONG-TERM SURVIVAL PROFILE AS POSTEROLATERAL THORACOTOMY IN CLINICAL N2 STAGE NON-SMALL CELL LUNG CANCER PATIENTS: A MULTICENTER, RANDOMIZED, CONTROLLED TRIAL,¿ MULTIPLE POST-OPERATIVE COMPLICATIONS WERE NOTED IN RELATION TO RATS PROCEDURES. AT THIS TIME, THE CAUSES OF THE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE COMPLICATIONS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }