{ "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": "2955842-2026-22620", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260423", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20260323", "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": "20260423", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251031", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1022555", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260423", "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": "U10251031 0060", "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(17)271031(10)U10251031", "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": "GA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260424", "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": "20260423", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " D" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20260422", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24961585", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260325", "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": "399208164", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE VESSEL SEALER CURVED INSTRUMENT IS NOT AVAILABLE FOR INVESTIGATION AS IT IS SINGLE USE AND WAS DISCARDED AFTER THE PROCEDURE. REVIEW OF THE INTRAOPERATIVE SYSTEM LOGS FOR THE DURATION OF THE PROCEDURE SHOW THE SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO INDICATIONS RELATING TO THIS EVENT. REVIEW OF THE LOGS FOR THE FIVE SUBSEQUENT PROCEDURES FOUND THE SYSTEM FUNCTIONED NORMALLY, NO INTRAOPERATIVE EVENTS OR ISSUES WERE FOUND. REVIEW OF THE VESSEL SEALER CURVED LOGS FOUND THAT THE INSTRUMENT WAS USED FOR ABOUT 40 MINUTES WITH NO ERRORS. THE E-200 GENERATOR ACTIVATION EVENT LOGS ALSO FOUND NO ERRORS. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: ENDOSCOPE 30 DEGREE, PROGRASP FORCEPS, PERMANENT CAUTERY HOOK, MEDIUM-LARGE CLIP APPLIER, LARGE SUTURECUT NEEDLE DRIVER, FENESTRATED BIPOLAR FORCEPS, TIP-UP FENESTRATED GRASPER. A SITE REVIEW FOUND THAT NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THE PRODUCTS USED. VIDEO FROM THE PROCEDURE WAS PROVIDED FOR INVESTIGATION. REVIEW OF THE VIDEO BY A CLINICAL DEVELOPMENT ENGINEER FOUND THAT THERE WAS NO OBSERVED PRODUCT MALFUNCTION RELATED TO UNEXPECTED ENERGY DELIVERY OR EXCESSIVE THERMAL SPREAD IN THE VIDEO. THE OBSERVED PATTERN OF TISSUE EFFECT FOLLOWING ENERGY ACTIVATION APPEARED NOMINAL. THERE WERE NO OBSERVED INSTANCES OF PRODUCT MALFUNCTIONS RELATED TO THE REPORTED UNEXPECTED JAW MOTION DURING THE VIDEO; NO INSTANCES OF THE JAWS OPENING IN A MORE RAPID OR SUDDEN MANNER THAN EXPECTED WERE IDENTIFIED. REVIEW OF THE CASE VIDEO BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) FOUND SEVERAL SIGNIFICANT BLEEDING EVENTS WITH VISUAL SUGGESTION OF AGGRESSIVE DISSECTION, EXCESSIVE TENSION OF MAJOR VESSELS, AND ENERGY ACTIVATION OF THE VSC WITHOUT FULL VISUALIZATION OF THE TISSUE GRASPED AND IN CLOSE PROXIMITY TO THE AORTA THROUGHOUT THE RECORDED VIDEO. THE FINAL BLEEDING EVENT VISIBLE ON THE VIDEO BEGINS WHEN THE VSC WAS USED NEAR THE AORTA WHILE A BEDSIDE ASSIST LAPAROSCOPIC SUCTION DEVICE WAS PLACING WHAT APPEARS TO BE SIGNIFICANT DOWNWARD TRACTION ON THE CELIAC TRUNK VIA NEARBY VESSELS BRANCHING FROM THE CELIAC TRUNK. THE BLEEDING BECOMES FURTHER ACCENTUATED WHEN PLACEMENT OF A BULLDOG CLAMP ON THE CELIAC IS ATTEMPTED WHICH APPEARS TO FURTHER INJURE THE CELIAC TRUNK. BASED ON THE AVAILABLE INFORMATION, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT." }, { "mdr_text_key": "399208165", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIAN ARCUATE LIGAMENT SYNDROME RELEASE (MALS) PROCEDURE, THE PATIENT EXPERIENCED INTRAOPERATIVE BLEEDING FROM THE AORTA AND ULTIMATELY EXPIRED. THE VESSEL SEALER CURVED (VSC) INSTRUMENT WAS BEING USED FOR BLUNT DISSECTION AND CAUTERY WHEN SIGNIFICANT BLEEDING OCCURRED FROM THE AORTA. THE PROCEDURE WAS EMERGENTLY CONVERTED TO AN OPEN APPROACH. WHEN AN ASSISTING VASCULAR SURGEON CROSS CLAMPED THE AORTA DURING REPAIR ATTEMPTS, THE PATIENT¿S PULSE WAS LOST AND CHEST COMPRESSIONS WERE STARTED. WITH NO RETURN OF A PULSE, THE CROSS CLAMPS ON THE AORTA WERE REMOVED AND BLEEDING CONTINUED WITH THE CHEST COMPRESSIONS. THE PATIENT EXPIRED IN THE OPERATING ROOM. THE SURGEON STATED THAT THE CAUSE OF THE AORTIC INJURY WAS UNKNOWN. THE SURGEON REPORTED THAT THROUGHOUT THE PROCEDURE, IT WAS NOTICED THAT THE VSC PRODUCED INCREASED THERMAL SPREAD AND INCREASED BLEEDING AFTER ENERGY ACTIVATION WHEN COMPARED TO THE VESSEL SEALER EXTEND. IT WAS ALSO STATED THAT THE VSC JAW MOVEMENT WOULD OPEN A LITTLE SLOWLY AT FIRST, THEN WOULD SPRING OPEN QUICKLY, WITH INCREASED BLEEDING FROM THE FAST JAW OPENING. NO ADDITIONAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }