{ "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": "2955842-2026-15973", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260314", "manufacturer_address_2": "", "pma_pmn_number": "K250674", "date_of_event": "20260216", "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": "20260314", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250929", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "661098", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260314", "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": "U10250929 0152", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260220", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874123369", "udi_public": "(01)10886874123369(10)U10250929", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Entrapment of Device" ], "reporter_state_code": "UT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/12/2026", "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": "20260314", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "72 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260331", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24600315", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260216", "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": "397296049", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: INITIAL FINDINGS WERE CONFIRMED. NO FUNCTIONAL ISSUES WERE FOUND WITH THE INSTRUMENT. LOGS WERE REVIEWED TO CHECK FOR ANY SEALING ISSUES/MALFUNCTIONS TO VERIFY THE CUSTOMER COMPLAINT. THE INSTRUMENT WAS USED FOR ABOUT 69 MINUTES, AND QTY 417 SEAGULL_SEAL EVENTS WERE NOTED, WITH NO ERRORS. NO SEALING ISSUES WERE IDENTIFIED FROM THE LOGS." }, { "mdr_text_key": "397296050", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395598917", "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. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE CUT TEST WITH NO ISSUES. THE INSTRUMENT PASSED ENERGY-DELIVERY TESTING ACROSS VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. THE LOGS SHOW NO VESSEL SEALER CURVED RELATED ERRORS. THE FIRST VESSEL SEALER CURVED INSTRUMENT (LOT # U10250929-0152) INSTRUMENT WAS USED FOR 69 MINUTES AND THE SECOND VESSEL SEALER CURVED INSTRUMENT WAS USED FOR ABOUT 17 MINUTES. THE ACTIVATION EVENT LOGS SHOW A TOTAL OF 417 EVENTS BETWEEN THE TWO INSTRUMENTS, WITH NO ERRORS. ." }, { "mdr_text_key": "395598918", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TRANSVERSE COLECTOMY PROCEDURE, THE VESSEL SEALER CURVED INSTRUMENT PRODUCED AN INCOMPLETE SEAL CYCLE ON THE INFERIOR MESENTERIC ARTERY (IMA) AND THE INSTRUMENT BECAME STUCK TO TISSUE. ANOTHER INSTRUMENT WAS USED TO PRY THE STUCK TISSUE FROM THE VESSEL SEALER CURVED INSTRUMENT. THE ATTEMPTED SEALED TISSUE OF THE IMA WAS INSPECTED AND FOUND THAT THE TISSUE DID NOT SEAL. THE TISSUE WAS NOT CUT. THE SURGEON OPTED TO STAPLE BOTH SIDE OF THE VESSEL TO REINFORCE THE SEAL. NO BLEEDING OCCURRED DUE TO THE INSUFFICIENT SEAL. THE PROCEDURE WAS COMPLETED ROBOTICALLY." } ], "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": "03/31/2026" } ] }