{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "950 KIFER RD.",
      "manufacturer_contact_pcity": "40852372",
      "event_type": "Death",
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      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20091125",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K070684",
      "date_of_event": "20091103",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "94086",
      "reporter_occupation_code": "NOT APPLICABLE",
      "manufacturer_contact_plocal": "4085237228",
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      "manufacturer_contact_l_name": "VANE",
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      "date_added": "20091210",
      "manufacturer_contact_f_name": "KAREN",
      "device_date_of_manufacturer": "20080501",
      "previous_use_code": "R",
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        {
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          "date_removed_flag": "",
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          "date_received": "20091125",
          "brand_name": "DA VINCI S SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS2000 A5.1P.8",
          "catalog_number": "",
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          "device_age_text": "DA",
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          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      ],
      "product_problems": [
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      "reporter_state_code": "MN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "12/24/2009",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260609",
      "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": "20091125",
          "sequence_number_treatment": [
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            " ACCESSORIES",
            " ELECTROSURGICAL UNIT"
          ],
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          "patient_age": "",
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          "patient_ethnicity": "",
          "patient_race": "",
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        }
      ],
      "distributor_city": "",
      "date_report": "20091224",
      "initial_report_to_fda": "Unknown",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SUNNYVALE",
      "mdr_report_key": "1553131",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20091105",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer 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": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "20616926",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT APPROXIMATELY SIX HOURS INTO A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE SURGEON DECIDED TO COMPLETE THE PROCEDURE VIA A THORACOTOMY. IT WAS REPORTED THAT THE PT EXPIRED SHORTLY AFTER THE PROCEDURE. REPORTEDLY, THE PT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM."
        },
        {
          "mdr_text_key": "20829254",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE HOSPITAL WAS CONTACTED TO OBTAIN ADD'L INFO, HOWEVER, DESPITE SEVERAL ATTEMPTS, THE SITE HAS DECIDED TO NOT PROVIDE ANY INFO RELATED TO THIS EVENT. NO MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE, AND THE HOSPITAL HAS CONTINUED TO USED THE SYSTEM TO PERFORM SURGERY ON PATIENTS. AS OF 2009, NO SIMILAR INSTANCES OF THIS EVENT HAVE BEEN REPORTED TO ISI."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "94086",
      "manufacturer_contact_exchange": "408",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "12/24/2009"
    }
  ]
}