{ "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": "2955842-2023-19914", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20231106", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20231011", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20231107", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1334341", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20231106", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "L80221206 0001", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)241130(10)L80221206", "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": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20231106", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "72 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "Black Or African American", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Great Vessel Perforation", "Hemorrhage/Blood Loss/Bleeding", "Great Vessel Perforation" ] } ], "distributor_city": "", "date_report": "20231011", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18081318", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231011", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "327472799", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, THERE HAVE BEEN 15 PROCEDURES PERFORMED SINCE THE EVENT DATE WITH NO RELEVANT COMPLAINTS RECEIVED. REVIEW OF THE SYSTEM LOGS FOR THE 5 SUBSEQUENT PROCEDURES AFTER THE REPORTED EVENT ALSO FOUND NO ERRORS THAT WOULD HAVE CONTRIBUTED TO AN ADVERSE EVENT. A SITE REVIEW OF THE INSTRUMENTS USED DURING THE PROCEDURE FOUND THAT ALL OF THE MULTIPLE USE INSTRUMENTS (ENDOSCOPE PLUS 30 DEGREE, MONOPOLAR CURVED SCISSORS, FORCE BIPOLAR FORCEPS) FOUND NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THE INSTRUMENTS SUBSEQUENT TO THE REPORTED PROCEDURE. THE HARMONIC ACE SHEARS IS A SINGLE USE ITEM. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THE VENA CAVA WAS INADVERTENTLY INJURED WHILE USING THE HARMONIC ACE SHEARS WHEN THE SURGEON GRASPED A NEARBY LIGAMENT AND ENCOUNTERED UNEXPECTED ANATOMY. THIS RESULTED IN A CATASTROPHIC BLEEDING EVENT AND THE PATIENT EXPIRED. ALTHOUGH NO ALLEGATION WAS MADE REGARDING ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF INTUITIVE SURGICAL INSTRUMENTS CONTRIBUTED TO THIS EVENT." }, { "mdr_text_key": "327472800", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED HIATAL HERNIA REPAIR, THE INFERIOR VENA CAVA (IVC) WAS INJURED. THE SURGEON REPORTED THAT THE INJURY OCCURRED DUE TO ATYPICAL ANATOMY. WHILE USING THE HARMONIC ACE SHEARS TO DIVIDE THE GASTROHEPATIC LIGAMENT, A MALPOSITION OF THE IVC RELATIVE TO ITS NORMAL POSITION WAS ENCOUNTERED. THE IVC WAS TENSELY PULLED ACROSS THE DIAPHRAGM AND UNRECOGNIZED AS IT WAS TUCKED RIGHT BEHIND THE GASTROHEPATIC LIGAMENT. THE SURGEON BELIEVES THE SIDEWALL OF THE IVC WAS UNKNOWINGLY GRASPED IN THE INSTRUMENT JAWS WHILE DIVIDING THE LIGAMENT. THE PROCEDURE WAS CONVERTED TO OPEN TO ADDRESS THE INJURY, BUT THE PATIENT EXPIRED. THERE WAS NO REPORTED INTUITIVE SURGICAL, INC. (ISI) PRODUCT MALFUNCTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }