{ "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": "2955842-2026-04141", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260217", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20251031", "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", "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": "20260217", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250603", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "427408", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260217", "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": "U10250603 0169", "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": "10886874123369", "udi_public": "(01)10886874123369(10)U10250603", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Deliver Energy", "Failure to Seal" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260217", "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", "date_received": "20260217", "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" ] } ], "distributor_city": "", "date_report": "20260217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24366552", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260122", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "393181203", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE VESSEL SEALER INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. VESSEL SEALER INSTRUMENT LOGS SHOW THE INSTRUMENT WAS INSTALLED ONCE ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. E-200 ENERGY ACTIVATION LOGS SHOWED 137 SEAL ACTIVATIONS AND 1 COAGULATION/BIPOLAR ACTIVATION WITH THIS INSTRUMENT AND ALL ACTIVATIONS WERE COMPLETED SUCCESSFULLY PER THE LOGS. METRICS SHOWED 133 SUCCESSFUL CUTS WITH 0 EXPOSED BLADES AND 0 HIGH IMPEDANCE SEALS. THE LOGS DID NOT APPEAR TO SHOW ANY ERRORS RELATED TO THE USE OF THE INSTRUMENT." }, { "mdr_text_key": "393181204", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING AND REQUIRED AN ANGIOGRAM. THE INITIAL ROBOTIC PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THERE WAS NO EXCESSIVE INTRAOPERATIVE BLEEDING NOTED. THE VESSEL SEALER CURVED INSTRUMENT WAS USED ON THE INFERIOR PANCREATIC DUODENAL BRANCH OFF THE SUPERIOR MESENTERIC ARTERY, WHERE THE BLEEDING WAS IDENTIFIED POSTOPERATIVELY. THE VESSEL WAS APPROXIMATELY 2MM IN DIAMETER. THE BLEEDING WAS CONTROLLED BY THE ANGIOGRAM; NO FURTHER INTERVENTION WAS REQUIRED, AND THE PATIENT DID NOT HAVE TO BE TAKEN BACK TO THE OPERATING ROOM." } ], "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": "" } ] }