{ "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": "Death", "report_number": "2955842-2025-05720", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250306", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20250203", "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", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250307", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240829", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "870599", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250306", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-06", "catalog_number": "480440", "lot_number": "K11240829 0092", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)260831(10)K11240829", "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": "05/01/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250306", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels", "Hemorrhage/Blood Loss/Bleeding", "Perforation of Vessels" ] } ], "distributor_city": "", "date_report": "20250207", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21543262", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250207", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "365192609", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION, THE BRACHIOCEPHALIC ARTERY WAS INJURED AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT EXPIRED ON POST-OPERATIVE DAY ONE. THE SURGEON REPORTED THAT THE ARTERY WAS INJURED WHEN USING THE SYNCHROSEAL INSTRUMENT TO DISSECT LYMPH NODES. THE ARTERY WAS ADHERED TO TISSUE AND TO THE LYMPH NODES, RESULTING IN THE ARTERY NOT BEING VISIBLE TO THE SURGEON. THE ARTERY BEGAN TO BLEED AFTER IT WAS GRASPED WITH THE SYNCHROSEAL INSTRUMENT. THE PROCEDURE WAS CONVERTED TO THORACOTOMY. THERE WAS NO MALFUNCTION OF THE SYNCHROSEAL INSTRUMENT OR ANY OTHER DA VINCI PRODUCTS USED DURING THIS PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED." }, { "mdr_text_key": "365192610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, CURVED BIPOLAR DISSECTOR, TIP-UP FENESTRATED GRASPER, FENESTRATED BIPOLAR FORCEPS, MEDIUM-LARGE CLIP APPLIER, SYNCHROSEAL. A SITE HISTORY REVIEW FOUND NO RELATED COMPLAINTS WERE RECEIVED FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) USED DURING THE PROCEDURE AND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT HAD A CATASTROPHIC INJURY TO THE INNOMINATE ARTERY WHILE ATTEMPTING TO REMOVE A MEDIASTINAL MASS AND ADHERENT LYMPH NODES IN THE VICINITY OF THIS LARGE ARTERY. THE SURGEON COMMENTED THEY DID NOT RECOGNIZE THE ARTERY AS THEY WERE ATTEMPTING TO DISSECT THE NEARBY LYMPH NODES AND INADVERTENTLY GRASPED THIS LARGE VESSEL. THIS SYNCHROSEAL IS NOT INTENDED FOR MAJOR ARTERIES AND THIS IS A SURGICAL TECHNIQUE ERROR. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT." }, { "mdr_text_key": "370731823", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A REVIEW OF THE SYSTEM LOGS FOUND THAT NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM FOUND NO ERRORS OCCURRED THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT." }, { "mdr_text_key": "370731824", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "05/20/2025" } ] }