{ "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": "2955842-2026-20832", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260411", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20260305", "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": "20260412", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251002", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "911085", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260411", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "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": "480275-12", "catalog_number": "480275", "lot_number": "K12251002 0232", "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": "10886874112738", "udi_public": "(01)10886874112738(10)K12251002", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Seal" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "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": "20260411", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Arrest", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260410", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24851725", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260319", "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": "398173745", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "398173746", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED WEDGE RESECTION GASTRECTOMY PROCEDURE, THE PATIENT SUSTAINED POSTOPERATIVE BLEEDING AND REQUIRED A SUBSEQUENT PROCEDURE. THE INITIAL ROBOTIC PROCEDURE WAS PERFORMED FOR A SMALL TUMOR IN THE UPPER STOMACH. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS RELATED TO INSTRUMENTS OR ROBOTICS. THE SURGEON USED A STAPLER TO COME ACROSS THE TUMOR OF THE STOMACH. THE HARMONIC ACE INSTRUMENT WAS USED ON THE SHORT GASTRIC OF THE STOMACH. THERE WAS NO INTRAOPERATIVE BLEEDING. THE PATIENT WAS TRANSFERRED TO THE POST-ANESTHESIA CARE UNIT (PACU), WHERE POSTOPERATIVE LABS WERE OBTAINED AND WERE WITHIN NORMAL LIMITS. APPROXIMATELY TWO HOURS LATER, THE PATIENT SUDDENLY BECAME HYPOTENSIVE AND WAS EMERGENTLY BROUGHT BACK TO THE OPERATING ROOM FOR A LAPAROTOMY. 2 LITERS OF BLOOD WERE FOUND WITHIN THE PATIENT'S ABDOMEN. THE PATIENT CODED ON THE TABLE, CARDIOPULMONARY RESUSCITATION WAS STARTED, AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THERE WAS NO ACTIVE BLEEDING IDENTIFIED WITHIN THE ABDOMEN. IT WAS UNKNOWN IF THE HARMONIC ACE WAS THE REASON FOR THE PATIENT'S COMPLICATIONS. THE PATIENT IS REPORTED TO BE RECOVERING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL." } ], "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": "" } ] }