{
  "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",
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      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_state": "",
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      "event_type": "Injury",
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      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20140227",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "ATTORNEY",
      "manufacturer_contact_plocal": "",
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      "date_added": "20140228",
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          "implant_flag": "",
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          "device_sequence_number": "120941",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20140227",
          "brand_name": "DA VINCI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC,",
          "manufacturer_d_address_1": "950 KIFER RD.",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "94086",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94086",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
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          "device_report_product_code": "NAY",
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          "device_evaluated_by_manufacturer": "",
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          "udi_di": "",
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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "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": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20140227",
          "sequence_number_treatment": [
            "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES",
            " DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            ""
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
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          "patient_problems": [
            "Injury"
          ]
        }
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3651923",
      "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": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "11651686",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS MEDWATCH REPORT REFLECTS 1,387 INITIAL EVENTS AND 19 SUPPLEMENTAL EVENTS SUMMARIZED AS PART OF (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED, FOLLOW UP REPORTS WILL BE SUBMITTED TO THE FDA. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT."
        },
        {
          "mdr_text_key": "4320437",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ATTORNEYS HAVE ALLEGED THAT THEIR CLIENTS SUFFERED INJURIES ASSOCIATED WITH DA VINCI SURGICAL PROCEDURES. THESE CLAIMS DO NOT INVOLVE DEATHS. THESE ALLEGATIONS WERE FIRST RECEIVED BY INTUITIVE SURGICAL DURING THE TIME PERIOD OF (B)(4) 2013 TO (B)(4) 2014. FOR THOSE CLAIMS WHERE PROCEDURE DATES ARE PROVIDED, THE DATES RANGE FROM (B)(6) 2004 THROUGH (B)(6) 2014."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}