{
  "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": "2955842-2024-12217",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20240315",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K131861",
      "date_of_event": "20240216",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "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": "20240315",
      "manufacturer_contact_f_name": "IZABEL",
      "device_date_of_manufacturer": "20221207",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "476437",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20240315",
          "brand_name": "DA VINCI XI",
          "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED",
          "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": "380723-15",
          "catalog_number": "380723",
          "lot_number": "N/A",
          "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": "00886874115374",
          "udi_public": "(01)00886874115374",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Non Reproducible Results",
        "Non Reproducible Results"
      ],
      "reporter_state_code": "SC",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250819",
      "health_professional": "",
      "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": "20240315",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20240216",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "18914641",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240216",
      "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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "337789839",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA REPAIR SURGICAL PROCEDURE, THE SURGEON FELT A SHOCK PULSING SENSATION IN HIS FOOT WHEN PRESSING THE FOOT PEDAL. THE SURGEON REPORTED WHEN HE PRESSED THE COAGULATION PEDAL, AN IMMEDIATE INTENSE PULSATING SHOCK SENSATION FROM HIS RIGHT GREAT TOE TO HIS HIP, WHEN RELEASING THE PEDAL, IT WOULD STOP WITH NO LINGERING SENSATION AT ALL, OCCURRING APPROXIMATELY 4-5 TIMES DURING THE PROCEDURE. (CLOG SLIP-ON SHOES WERE WORN). THE PROCEDURE WAS CONTINUED WITH THE FENESTRATED BIPOLAR FORCEPS AND NOT THE COAGULATION BUTTON FOR THE REMAINDER OF THE PROCEDURE. THERE IS NO INJURY FROM THIS EVENT AND THE PROCEDURE WAS COMPLETED AS PLANNED."
        },
        {
          "mdr_text_key": "337789840",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE REPORTED EVENT AT THE CUSTOMER SITE. THE SURGEON SIDE CONSOLE (SSC) WAS ANALYZED; THE COMPLAINT WAS NOT CONFIRMED. FSE RAN ELECTRICAL SAFETY TESTS, NO ELECTRICAL ISSUES WERE PRESENT ON THE SYSTEM. THE REPORTED PROBLEM WAS NOT REPRODUCED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE."
        }
      ],
      "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": ""
    }
  ]
}