{ "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": "+1(408)5", "event_type": "Death", "report_number": "2955842-2026-33713", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260730", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20260630", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "+1(408)523-2100", "noe_summarized": "1", "manufacturer_contact_l_name": "Nielson", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260731", "manufacturer_contact_f_name": "Izabel", "device_date_of_manufacturer": "20260416", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "134496", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260730", "brand_name": "da Vinci Energy", "generic_name": "Vessel Sealer Curved", "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": "480522-02", "catalog_number": "480522", "lot_number": "U10260416 0125", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20260728", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20260807", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20260730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "Santa Clara", "mdr_report_key": "50093840", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260630", "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": "15311997468", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "It was reported that during a da Vinci-assisted sliding hiatal hernia procedure, after sealing and cutting of an unspecified branch of the aorta, bleeding occurred and the patient ultimately expired.The surgeon reported that the Vessel Sealer Curved (VSC) instrument seal and cut cycle worked as expected with no error messages. However, when the jaws of the VSC were opened, the sealed branch started to hemorrhage. The procedure continued robotically for approximately one hour in attempts to fully stop the bleeding which was able to be controlled at multiple points after the initial seal. The estimated blood loss during the robotic portion was approximately 2 liters when a mass transfusion protocol was initiated and the procedure was converted to a thoracotomy but the surgeon was unable to control the bleeding. The aorta was then cross-clamped and the bleeding stopped; however, the patient expired in the operating room. The surgeon reports there were no error messages or robotic-related complications that occurred during the procedure. Specifically, the VSC worked as expected with no error messages or complications with sealing during use." }, { "mdr_text_key": "15811997469", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "Intuitive Surgical Inc. (ISI) received the Vessel Sealer Curved instrument associated with this complaint. Failure Analysis did not show any issues with the instrument. Visual inspection displayed no signs of physical damage or abnormalities at the distal or proximal end of the instrument, that could have contributed to the reported complaint. The instrument was returned with the integrated cord cut off, no functional energy delivery testing could be performed. The instrument passed continuity test for both jaws in multiple wrist orientations, indicating that it's unlikely for the conductor wire to be broken at weld inside the jaw. The instrument jaws were CT scanned to check for any wire breaks at weld. No breaks at the weld were noted from the CT images. The following concomitant products were used during this procedure: Endoscope 30 Degree, Fenestrated Bipolar Forceps, Cadiere Forceps, two Medium-Large Clip Appliers, Large Clip Applier, Vessel Sealer Curved, and Suction Irrigator. A site review found that no complaints have been reported for any of the products used.Review of the System logs found no errors were logged during the procedure. Log review of the (5 )subsequent procedures performed on the system also found no errors occurred.A review of the Vessel Sealer Extend logs found the instrument was installed once and passed homing. The sealing events were completed with no relevant errors noted.An Intuitive Surgical Medical Safety Officer (MSO) review of the event was performed and concluded that the patient in this report died during a hiatal hernia repair. A VSC was being used for vessel sealing when bleeding from the aorta occurred after release of the VSC jaws. The specific vessel that the surgeon was attempting to seal was not provided. A review of the event did not demonstrate any device related issues. Based on the information provided in the summary of events, no Intuitive Surgical product or instrument contributed to this event." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 Central Expressway", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }