{
  "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": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
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      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Death",
      "report_number": "2955842-2012-00169",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20120418",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
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      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
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        "User facility"
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20120419",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120418",
          "brand_name": "DA VINCI SI 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": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS3000 A6.0P6",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "R",
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          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "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": "20120418",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Death"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20120319",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2539857",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120504",
      "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": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "2588529",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT APPROXIMATELY ONE YEAR AGO, A PATIENT EXPIRED AFTER UNDERGOING A DA VINCI SI GYNECOLOGICAL PROCEDURE."
        },
        {
          "mdr_text_key": "9798247",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2012, THE INITIAL REPORTER INFORMED INTUITIVE SURGICAL THAT THE PATIENT DEATH WAS NOT RELATED TO SURGICAL ERROR, NOR WAS IT RELATED TO THE ANESTHESIA ADMINISTERED TO THE PATIENT. THE INITIAL REPORTER ALSO INDICATED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT MALFUNCTION DURING THE SURGICAL PROCEDURE. DUE TO HIPAA REGULATIONS, THE INITIAL REPORTER WAS UNWILLING TO PROVIDE ANY FURTHER INFORMATION."
        },
        {
          "mdr_text_key": "16331204",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2012, A HOSPITAL REPRESENTATIVE INFORMED INTUITIVE SURGICAL THAT THE PATIENT DEATH HAD NOTHING TO DO WITH THE USE OF THE DA VINCI SI SURGICAL SYSTEM AND THE PATIENT ISSUE WOULD HAVE OCCURRED REGARDLESS OF HOW THE SURGICAL PROCEDURE WAS PERFORMED."
        }
      ],
      "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": "06/01/2012"
    }
  ]
}