{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "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": "MW5149649",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20231227",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20231215",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT FAMILY MEMBER OR FRIEND",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20231229",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "2263942",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20231227",
          "brand_name": "DA VINCI ROBOT",
          "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "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": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
      "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": "20231227",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Disability",
            " O",
            " H"
          ],
          "patient_age": "65 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "Non Hispanic",
          "patient_race": "White",
          "patient_problems": [
            "Laceration(s)",
            "Necrosis",
            "Unspecified Vascular Problem",
            "Unspecified Gastrointestinal Problem",
            "Laceration(s)",
            "Necrosis",
            "Unspecified Vascular Problem",
            "Unspecified Gastrointestinal Problem"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20231224",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "18411205",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "331635067",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "MY MOTHER SUFFERED SERIOUS COMPLICATIONS DURING A FUNDOPLICATION SURGERY USING THE DA VINCI ROBOT MADE MY INTUITIVE SURGICAL. A PRIMARY BLOOD VESSEL TO HER STOMACH WAS SEVERED CAUSING THE ORGAN TO DIE. SHE HAS CONTINUED TO HAVE ISSUES WITH PERFUSION TO HER INTESTINES REQUIRING MULTIPLE FOLLOW UP PROCEDURES TO REMOVE MORE NECROTIC TISSUE. AT THIS POINT WE ARE UNSURE IF SHE WILL SURVIVE AND IF SHE DOES SHE WILL BE DEPENDENT ON OTHERS FOR HER CARE FOR THE REMAINDER OF HER LIFE. SHE WAS PREVIOUSLY AN ACTIVE 65 YO GRANDMOTHER. THIS MATTER NEEDS TO BE INVESTIGATED FULLY. THE PROCEDURE WAS DONE BY DR (B)(6) AT (B)(6) HOSPITAL IN (B)(6). PROCEDURE DATE IS (B)(6) 2023."
        }
      ],
      "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": ""
    }
  ]
}