{
  "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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      "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",
      "report_number": "2955842-2010-00007",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
      "date_received": "20100108",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K070947",
      "date_of_event": "20091203",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "BIOMEDICAL ENGINEER",
      "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": "20100120",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20100108",
          "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": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS2000 A6.0P2",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "GA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250729",
      "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": "20100108",
          "sequence_number_treatment": [
            "INSTRUMENTS",
            " ACCESSORIES",
            " DA VINCI SI SYSTEM"
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "50 YR",
          "patient_sex": "",
          "patient_weight": "91",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20091210",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1580191",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20091210",
      "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": "21228488",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "AN INVESTIGATION CONDUCTED BY AN ISI CLINICAL SALES REP FOUND THAT THE SURGEON WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE PT'S INJURY, HOWEVER, THE SURGICAL TEAM EVALUATED THE FOLLOWING FACTORS AS POSSIBLE CONTRIBUTORS. PT SIDE ASSISTANT WAS LEANING ON PT'S RIGHT ARM DURING PART OF THE PROCEDURE. SURGICAL STAFF TUCKED PT'S RIGHT ARM TOO CLOSELY TO THE PT DURING PROCEDURE. SCARING TISSUE FROM PT'S PREVIOUS ROTATOR CUFF SURGERY ON RIGHT ARM. AS OF 2010, THE HOSP HAS CONTINUED TO USE THE SYSTEM WITH NO REPORTED RECURRENCES OF THE REPORTED ISSUE."
        },
        {
          "mdr_text_key": "20996440",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED."
        }
      ],
      "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": ""
    }
  ]
}