{
  "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": {
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  "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": "2955842-2026-16179",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260316",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K182371",
      "date_of_event": "20260219",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "4085232100",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "NIELSON",
      "source_type": [
        "Other",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260316",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20251215",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "671500",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260316",
          "brand_name": "DA VINCI SP",
          "generic_name": "PATIENT SIDE CART",
          "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": "380601-55",
          "catalog_number": "N/A",
          "lot_number": "N/A",
          "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": "00886874114605",
          "udi_public": "(01)00886874114605",
          "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"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260504",
      "health_professional": "",
      "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": "20260316",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES."
          ],
          "sequence_number_outcome": [
            "Hospitalization"
          ],
          "patient_age": "NA",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "White",
          "patient_problems": [
            "Bone Fracture(s)"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260316",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "24609283",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260219",
      "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": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "395712038",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SINGLE-PORT (SP) RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE, THE PATIENT SUSTAINED A RIB INJURY ADJACENT TO THE ACCESS PORT. THIS WAS NOTED AT THE COMPLETION OF THE PROCEDURE WHEN THE ROBOT WAS UNDOCKED AND WHEN IT WAS TIME TO CLOSE. THE PATIENT WAS POSITIONED ON THE TRUMPF BED AND SLID DURING THE PROCEDURE, CONTRIBUTING TO THE RIB FRACTURE ADJACENT TO THE ACCESS PORT. THE INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE WHO WAS PRESENT ATTRIBUTED THIS TO THE PATIENT'S HIGHER BODY MASS INDEX (BMI) AND FEET NOT BEING SECURED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND DUE TO THE INJURY, THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. NO SCANS WERE PERFORMED INTRAOPERATIVELY. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN SP SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED."
        },
        {
          "mdr_text_key": "395712039",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THERE IS NO ALLEGATION AGAINST A DA VINCI PRODUCT ASSOCIATED WITH THIS EVENT, THEREFORE; NO PRODUCT WAS RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION: BODY MASS INDEX (BMI) 38 KG/M2."
        }
      ],
      "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": ""
    }
  ]
}