{
  "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": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "MW5057570",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
      "date_received": "20151028",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20150603",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20151030",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "714528",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20151028",
          "brand_name": "ROBOTIC-ASSISTED DA VINCI SYSTEM",
          "generic_name": "ROBOTIC-ASSISTED DA VINCI SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "0",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "OR",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "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": "20151028",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " L",
            " R",
            " S"
          ],
          "patient_age": "59 YR",
          "patient_sex": "",
          "patient_weight": "66",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pain",
            "Perforation",
            "Sepsis"
          ]
        }
      ],
      "distributor_city": "",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "5191435",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "30054912",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2010, DR. (B)(6), PREPARED MY ABDOMINAL CAVITY WITH A VERESS NEEDLE TO REMOVE A CANCEROUS PROSTATE USING THE ROBOTIC-ASSISTED DAVINCI SYSTEM. ON (B)(6) 2010, ESCALATING PAIN RESULTED IN EXPLORATORY SURGERY WITH THE DISCOVERY OF ABDOMINAL SEPSIS AND A 20 CM THROUGH AND THROUGH PERFORATION TO MY SMALL INTESTINE. AN 8CM SEGMENT OF BOWEL WAS REMOVED AND A REPLACEMENT OF AN ILEOSTOMY FOLLOWED. ON (B)(6) 2010, SUCCESSFUL REVERSAL WAS PERFORMED. I ASKED THE DOCTOR WHAT HAPPENED. HE CLAIMED HE DID NOT KNOW. FOUR YEARS LATER, TWO UNSUCCESSFUL SCAR REVISIONS AND ONGOING MENTAL AND PHYSICAL HEALTH REHABILITATION, I HAD FINALLY FOUND ONE ANSWER TO MY QUESTIONS; WHAT CAUSED THE INJURY. ON (B)(6) 2014, (B)(6), FOUND THE PERFORATION WAS CONSISTENT WITH INJURIES FROM TROCARS, NOT DA VINCI. THEY DID NOT KNOW WHO INSERTED THE TROCAR. I DO NOT KNOW IF THE INJURY WAS DUE TO INEXPERIENCE, LACK OF ATTENTION, POOR JUDGEMENT OR VERESS NEEDLE FAILURE."
        }
      ],
      "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": ""
    }
  ]
}