{
  "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": "2955842-2026-36684",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "",
      "date_received": "20260827",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K181395",
      "date_of_event": "20260805",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "+1(408)523-2100",
      "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": "20260827",
      "manufacturer_contact_f_name": "Izabel",
      "device_date_of_manufacturer": "20260728",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1931283",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260827",
          "brand_name": "da Vinci Accessory",
          "generic_name": "UNIVERSAL SEAL",
          "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": "470500-14",
          "catalog_number": "470500",
          "lot_number": "N/A",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "GCJ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Laparoscope, General & Plastic Surgery",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Material Fragmentation"
      ],
      "reporter_state_code": "AZ",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "US",
      "date_changed": "20260827",
      "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": "20260827",
          "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": "20260827",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
      "mdr_report_key": "50484754",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260805",
      "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": "15593336860",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that during a da Vinci-assisted surgical procedure, the Universal Seal Accessory had a rubber piece break off. The fragment fell into the patient and was retrieved during the same procedure which was completed as planned."
        },
        {
          "mdr_text_key": "16093336861",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "The Universal Seal Accessory has not been received for failure analysis evaluation."
        }
      ],
      "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": ""
    }
  ]
}