{
  "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": "",
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      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
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      "event_type": "Death",
      "report_number": "2955842-2012-00235",
      "type_of_report": [
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K060391",
      "date_of_event": "20120417",
      "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_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20120529",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120525",
          "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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS2000 A5.1P8",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
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          "device_evaluated_by_manufacturer": "N",
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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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        }
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      "product_problems": [
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      "reporter_state_code": "MA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250806",
      "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": "20120525",
          "sequence_number_treatment": [
            "DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Death"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Death",
            "Hemorrhage/Blood Loss/Bleeding"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20120427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2589305",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120427",
      "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": "2642292",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, MINOR BLEEDING OCCURRED. THE BLEEDING WAS REGARDED AS NORMAL BLEEDING FROM MINOR VESSELS. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WENT INTO RECOVERY. THE PATIENT SEEMED FINE DURING RECOVERY; HOWEVER, AT AN UNKNOWN TIME AFTER THE SURGERY, THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "9889033",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "A REVIEW OF SYSTEM LOGS SHOWED THAT NO SYSTEM FAULTS OCCURRED DURING SURGERY. THERE WAS NO REPORT OF SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION RELATED TO THIS PROCEDURE. THE ROOT CAUSE OF DEATH IS THOUGHT TO BE EITHER INTUBATION OR THE RESULT OF BLEEDING. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE ACCOUNT WERE MADE. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. AS OF MAY 25, 2012, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM."
        }
      ],
      "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": ""
    }
  ]
}