{
  "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": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
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      "manufacturer_contact_state": "",
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      "manufacturer_contact_address_2": "",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "date_received": "20180806",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20161215",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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      ],
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20180807",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "596340",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20180806",
          "brand_name": "DA VINCI ROBOT",
          "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT",
          "manufacturer_d_name": "INTUITIVE SURGICAL INC.",
          "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": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "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": "CO",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250725",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "date_received": "20180806",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Disability"
          ],
          "patient_age": "38 YR",
          "patient_sex": "",
          "patient_weight": "64",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Pain",
            "Spinal Column Injury",
            "Pain",
            "Spinal Column Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20180802",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "7757075",
      "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": "116408914",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "HYSTERECTOMY WITH DA VINCI ROBOT AT (B)(6) HOSPITAL FOR 3.75 HOURS. WOKE WITH GRADE 4 ANNULAR TEAR IN L5-S1 LUMBAR DISC, CAUSING IMMEDIATE SEVERE PAIN AND REQUIRING ARTIFICIAL DISC REPLACEMENT 7 MONTHS LATER."
        }
      ],
      "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": ""
    }
  ]
}