{
  "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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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "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": "Injury",
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      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20130519",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20120214",
      "reprocessed_and_reused_flag": "",
      "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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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20130520",
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      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "220734",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20130519",
          "brand_name": "DA VINCI 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": "",
          "catalog_number": "",
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          "combination_product_flag": "N",
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          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
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      "product_problems": [
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      "reporter_state_code": "PA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250725",
      "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": "20130519",
          "sequence_number_treatment": [
            "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE"
          ],
          "sequence_number_outcome": [
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            " R"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Abdominal Pain",
            "Perforation",
            "Tissue Damage",
            "Burn, Thermal"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20130422",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3119090",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "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": "10845838",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "CORRECTED DATA CAN BE FOUND IN EVENT DATE = (B)(6) 2012."
        },
        {
          "mdr_text_key": "10759021",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT."
        },
        {
          "mdr_text_key": "3503116",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2012, I HAD A DA VINCI ASSISTED LAVH, BEING RELEASED THE FOLLOWING DAY ON (B)(6) 2012. I FELT AS THOUGH I WAS RECOVERING WELL FOR THE FIRST FEW DAYS. BEGAN HAVING ABDOMINAL PAIN ON (B)(6) 2012. RETURNED TO SURGEON ON (B)(6) 2012 BECAUSE I WAS NOT FEELING WELL. PUT ON ANTIBIOTIC AND SENT HOME. ON (B)(6), WENT TO ER AND WAS ADMITTED BECAUSE IT WAS DISCOVERED THAT MY RIGHT URETER HAD SUFFERED A THERMAL INJURY DURING MY HYSTERECTOMY AND MY CONTINUED DECLINE THE DAYS PRIOR WERE DUE TO THE INJURED URETER LEAKING URINE INTO MY ABDOMINAL CAVITY. AFTER TWO FAILED ATTEMPTS AT TREATING THE INJURY CONSERVATIVELY, I HAD TO BE OPENED UP, REOPERATED ON, AND MY BLADDER RECONSTRUCTED TO REACH MY NOW SHORTER URETER."
        }
      ],
      "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": "05/29/2013"
    }
  ]
}