{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "HOSPITAL",
      "report_to_fda": "Y",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "17623246",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20230825",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20230802",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20230810",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "RISK MANAGER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20230825",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1918360",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20230825",
          "brand_name": "DA VINCI XI",
          "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC",
          "manufacturer_d_address_1": "1266 KIFER ROAD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "94086",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94086",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "*",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "reporter_state_code": "AZ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "health_professional": "N",
      "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": "20230825",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention",
            " H"
          ],
          "patient_age": "24090 DA",
          "patient_sex": "Male",
          "patient_weight": "81 KG",
          "patient_ethnicity": "",
          "patient_race": "White",
          "patient_problems": [
            "Internal Organ Perforation",
            "Internal Organ Perforation"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20230810",
      "initial_report_to_fda": "Yes",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20230825",
      "manufacturer_contact_city": "",
      "mdr_report_key": "17623246",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20230810",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "321945581",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "SURGEON AND OTHER STAFF WERE USING THE DAVINCI XI FOR A UROLOGICAL PROCEDURE. THE OUTFIELD AND INFIELD MONITORS IN THE OPERATING ROOM FLICKERED MULTIPLE TIMES THROUGHOUT CASE IN OPERATING ROOM AND EVENTUALLY WENT BLACK. REDUCED VISUALIZATION AND INABILITY TO SEE VISION TOWER RESULTED IN SMALL NICK TO BLADDER NECK. PHYSICIAN ABLE TO REPAIR TEAR. THIS ISSUE OF MONITORS FLICKERING AND GOING BLACK HAS HAPPENED MANY TIMES BEFORE, BUT WITHOUT INJURY TO A PATIENT. MANUFACTURER RESPONSE FOR DAVINCI XI MONITORS, DAVINCI XI (PER SITE REPORTER). MANUFACTURER WILL ARRIVE NEXT WEEK TO TROUBLESHOOT THE DEVICE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}