{
  "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": "*",
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      "manufacturer_contact_address_1": "",
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      "date_received": "20160817",
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      "pma_pmn_number": "",
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      "manufacturer_contact_zip_code": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20160817",
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          "serviced_by_3rd_party_flag": "",
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          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
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          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "94086",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94086",
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "product_problems": [
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
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      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20160817",
          "sequence_number_treatment": [
            ""
          ],
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            ""
          ],
          "patient_age": "",
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          "patient_ethnicity": "",
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          ]
        }
      ],
      "distributor_city": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "5882020",
      "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": "",
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      "mdr_text": [
        {
          "mdr_text_key": "52295473",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THIS MEDWATCH REPORT REFLECTS 6 INITIAL EVENTS AND 25 SUPPLEMENTAL EVENTS SUMMARIZED AS PART OF EXEMPTION NUMBER E2013035. IF ADDITIONAL INFORMATION IS RECEIVED, FOLLOW-UP REPORTS WILL BE SUBMITTED TO THE FDA."
        },
        {
          "mdr_text_key": "52295474",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE REPORTABLE DEATHS OR MALFUNCTIONS. THESE ALLEGATIONS WERE RECEIVED BY INTUITIVE SURGICAL, INC.(ISI) BETWEEN APRIL 1, 2016 - JULY 1, 2016. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2012 - (B)(6) 2014."
        }
      ],
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}