{
  "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": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Death",
      "report_number": "2955842-2013-00512",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20130214",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20121207",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20130215",
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          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20130214",
          "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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
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            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20130214",
          "sequence_number_treatment": [
            "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Death"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20130115",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2962560",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130115",
      "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": "16013722",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A PATIENT EXPIRED APPROXIMATELY FOUR WEEKS AFTER AN ESOPHAGECTOMY PROCEDURE WAS PERFORMED. THE ROBOTICALLY-ASSISTED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES, AS IT WAS STATED TO HAVE BEEN DIFFICULT FOR A NUMBER OF REASONS, ACCORDING TO THE SURGEON. THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DISCHARGED THREE WEEKS AFTER THE PROCEDURE FOR REHABILITATION. THE PATIENT THEN DIED A WEEK LATER OF WHAT THE HOSPITAL STAFF BELIEVES TO BE DUE TO A PULMONARY EMBOLISM/OTHER CARDIORESPIRATORY RELATED EVENT. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME."
        },
        {
          "mdr_text_key": "16327850",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INTUITIVE SURGICAL CONTACTED (VIA PHONE AND EMAIL) THE INITIAL REPORTER IN REGARDS TO THIS COMPLAINT IN ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. IT WAS STATED THAT THE PROCEDURE LASTED A TOTAL OF 16 HOURS, AND THAT THERE WERE NO KNOWN DEFECTS OF ANY INTUITIVE SURGICAL INSTRUMENT(S)/ACCESSORY(IES) OR DA VINCI SI SYSTEM. NO FURTHER INFORMATION WAS KNOWN. IN ADDITION, THE ROBOTICS COORDINATOR AND OR MANAGER WERE CONTACTED (VIA PHONE AND EMAIL) FOR FURTHER INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED."
        }
      ],
      "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": ""
    }
  ]
}