{
  "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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      "event_location": "HOSPITAL",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "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": "2955842-2011-00313",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20110929",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20110718",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20110929",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20110929",
          "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",
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          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
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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": [
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      "reporter_state_code": "FL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "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": "20110929",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Death"
          ],
          "patient_age": "52 YR",
          "patient_sex": "",
          "patient_weight": "77",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Death",
            "Hemorrhage/Blood Loss/Bleeding",
            "Brain Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20110830",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2269019",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20110830",
      "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": "2235978",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT 56 HOURS AFTER A DA VINCI SI TORS (TRANSORAL ROBOTIC SURGERY) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED HEAVY BLEEDING AND CARDIOPULMONARY ARREST ENSUED. CPR WAS PERFORMED IN EXCESS OF 20 MINUTES BEFORE THE PATIENT'S PULSE WAS RESTORED AND AS A RESULT, IRREVERSIBLE ANOXIC BRAIN INJURY OCCURRED. ON (B)(6) 2011, THE PATIENT EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE OF THE PATIENT BLEEDING WAS UNDETERMINED. IT WAS ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THERE WERE NO SYSTEM FAILURES, NO INJURY TO THE PATIENT, AND NO COMPLICATIONS EXPERIENCED."
        },
        {
          "mdr_text_key": "9413252",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2011, THE SURGEON WHO PERFORMED THE TORS PROCEDURE INFORMED INTUITIVE SURGICAL THAT THEY WERE ADVISED NOT TO PROVIDE ANY ADDITIONAL INFORMATION."
        }
      ],
      "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": ""
    }
  ]
}