{
  "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": "2026-10-13",
    "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": "+1(408)5",
      "event_type": "Injury",
      "report_number": "2955842-2026-35951",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "",
      "date_received": "20260819",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K250674",
      "date_of_event": "20260722",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "501",
      "manufacturer_contact_plocal": "+1(408)523-2100",
      "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": "20260819",
      "manufacturer_contact_f_name": "Izabel",
      "device_date_of_manufacturer": "20260416",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "426962",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260819",
          "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": "K11260416 0244",
          "other_id_number": "",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20260804",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "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"
          }
        }
      ],
      "product_problems": [
        "Material Fragmentation"
      ],
      "reporter_state_code": "MI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "09/07/2026",
      "mfr_report_type": "",
      "manufacturer_contact_country": "US",
      "date_changed": "20260928",
      "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": "20260819",
          "sequence_number_treatment": [
            "da Vinci Instruments and Accessories."
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260928",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
      "mdr_report_key": "50323890",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "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": "",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "15512629930",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that during a da Vinci-assisted bowel resection procedure, the Vessel Sealer Curved instrument tip broke during the procedure and was retrieved during the same procedure. No patient complication was reported as a result of the event. A new instrument was obtained to continue and complete the surgery."
        },
        {
          "mdr_text_key": "16012629931",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "Intuitive Surgical, Inc. (ISI) received the da Vinci product for failure analysis. The Vessel Sealer Curved instrument was analyzed, and no physical damage was identified. The instrument moved intuitively with a full range of motion in all directions, and the grip tips opened and closed properly. The instrument also passed the cut test.The instrument was connected to an in-house energy generator and was recognized without issue. It successfully passed energy delivery testing in various grip orientations, as well as the electrical continuity test. The instrument was found to be fully functional.The complaint was not confirmed through failure analysis."
        }
      ],
      "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": "09/28/2026"
    }
  ]
}