{ "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": "2955842-2025-42030", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251029", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250404", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "US", "manufacturer_contact_area_code": "408", "date_added": "20251029", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "167368", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251029", "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": "CA", "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": "20251029", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pleural Effusion", "Hernia", "Hemorrhage/Blood Loss/Bleeding", "Pleural Effusion", "Hernia" ] } ], "distributor_city": "", "date_report": "20251029", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23413683", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251001", "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": "383731050", "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 ANY DA VINCI PRODUCT ISSUES, AND NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT EVENT INFORMATION. CITATION: AGNINO, A., ET AT. (2025). ROBOTIC-ASSISTED LEFT ATRIAL APPENDAGE OCCLUSION: AN IMPORTANT COMPLEMENTARY OPTION IN THE SURGICAL MANAGEMENT OF ATRIAL FIBRILLATION. INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY. HTTPS://DOI.ORG/10.1093/ICVTS/IVAF082." }, { "mdr_text_key": "383731051", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE TITLED, ¿ROBOTIC-ASSISTED LEFT ATRIAL APPENDAGE OCCLUSION: AN IMPORTANT COMPLEMENTARY OPTION IN THE SURGICAL MANAGEMENT OF ATRIAL FIBRILLATION,¿ WAS PERFORMED. PER THE ARTICLE, THE OBJECTIVE OF THE OBSERVATIONAL, RETROSPECTIVE, MULTICENTRE STUDY WAS TO DEMONSTRATE SAFETY, FEASIBILITY, AND EFFICACY OF LEFT ATRIAL APPENDAGE OCCLUSION (LAAO) PERFORMED BY A ROBOTIC-ASSISTED APPROACH. THE STUDY PERIOD WAS BETWEEN AUGUST 2019 AND JUNE 2024 AND INCLUDED 194 PATIENTS WHO UNDERWENT LAAO THROUGH LEFT THORACOSCOPY USING THE DA VINCI X OR XI SURGICAL SYSTEM AT TWO SITES. WITHIN THIS COHORT, 155 PATIENTS UNDERWENT CONCOMITANT EPICARDIAL ABLATION AS PART OF A HYBRID ATRIAL FIBRILLATION (AF) TREATMENT. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, FOUR PATIENTS IN THE FIRST PHASE EXPERIENCED POSTOPERATIVE LEFT HEMIDIAPHRAGM PARALYSIS REQUIRING SURGICAL APPLICATION IN THREE CASES. SPONTANEOUS RESOLUTION WAS OBSERVED IN THE FOURTH CASE. FOUR PATIENTS AMONG THOSE UNDERGOING ROBOTIC ASSISTED HYBRID ABLATION WITH A SUBXIPHOID ACCESS DEVELOPED A SUBXIPHOID INCISIONAL HERNIA WHICH REQUIRED SURGICAL REPAIR. ONE PATIENT REQUIRED THORACOSCOPIC REVISION DUE TO CHEST WALL BLEEDING. FIVE PATIENTS REQUIRED THORACENTESIS FOR NEW PLEURAL EFFUSIONS. BLOOD PRODUCT TRANSFUSION WAS NECESSARY IN ONE PATIENT, DUE TO SIGNIFICANT CHEST WALL BLEEDING REQUIRING THORACOSCOPIC RE-EXPLORATION. NO STROKE OR THROMBOEMBOLIC EVENTS WERE OBSERVED. LEFT HEMIDIAPHRAGM PARALYSIS REQUIRING PLICATION OCCURRED IN 3 PATIENTS (1.5%). HOSPITAL MORTALITY WAS 0%. THE MEAN LENGTH OF STAY (LOS) IN THE HOSPITAL WAS 2.2 DAYS (RANGE 1¿10 DAYS) AND ALL PATIENTS WERE DISCHARGED HOME. STUDY LIMITATIONS INCLUDED: PATIENT SELECTION AND OBSERVER BIASES; INHERENT DIFFERENCES BETWEEN PATIENT POPULATIONS AT THE TWO CENTERS; AND GENERALIZATIONS BEING DIFFICULT TO MAKE BASED ON INDIVIDUAL PRACTICES, LEVEL OF EXPERIENCE AND AVAILABILITY OF CERTAIN TECHNOLOGICAL FEATURES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL INC., (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT. HOWEVER, NO RESPONSE WAS RECEIVED FROM THE PHYSICIAN." } ], "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": "" } ] }