{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "SANTA CLARA",
      "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY",
      "manufacturer_contact_pcity": "40852321",
      "event_type": "Injury",
      "report_number": "2955842-2026-30246",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20260702",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20250609",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "4085232100",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "NIELSON",
      "source_type": [
        "Other",
        "Foreign",
        "Literature",
        "Health Professional"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260702",
      "manufacturer_contact_f_name": "IZABEL",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "70154",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260702",
          "brand_name": "DA VINCI SP OR SI",
          "generic_name": "PATIENT SIDE CART",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC",
          "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SANTA CLARA",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "95051",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "95051",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "UNKNOWN",
          "catalog_number": "UNKNOWN",
          "lot_number": "NA",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "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": [
        "Adverse Event Without Identified Device or Use Problem",
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "07/10/2026",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260814",
      "health_professional": "N",
      "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": "20260702",
          "sequence_number_treatment": [
            "DA VINCI INSTRUMENTS AND ACCESSORIES."
          ],
          "sequence_number_outcome": [
            "Required Intervention",
            " H"
          ],
          "patient_age": "56 YR",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Unspecified Kidney or Urinary Problem"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260710",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "25691146",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260605",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        "Other"
      ],
      "manufacturer_g1_zip_code": "95051",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "INTUITIVE SURGICAL, INC",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "406278856",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "A SYSTEM LOG REVIEW COULD NOT BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM OR INSTRUMENT IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION (APA): SURGICAL OUTCOMES OF THE NON-RENORRHAPHY TECHNIQUE DURING ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR HIGHLY COMPLEX RENAL TUMORS (RENAL SCORE > OR =10) 10.1111/IJU.70157 HAMADA-2025-SURGICAL OUTCOMES OF THE NON-RENOR.PDF. HTTPS://DOI.ORG/10.1111/IJU.70157."
        },
        {
          "mdr_text_key": "406278857",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "A REVIEW OF THE ARTICLE REPORTED THE FOLLOWING ADVERSE EVENT. URINARY LEAKAGE OCCURRED IN ONE PATIENT IN THE NONRENORRHAPHY GROUP AND TWO PATIENTS IN THE RENORRHAPHY GROUP; HOWEVER, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE GROUPS (P=0.9399). IN THE NONRENORRHAPHY GROUP, ONE PATIENT DEVELOPED A URINOMA REQUIRING READMISSION. URINARY LEAKAGE DID NOT IMPROVE WITH URETERAL STENTING AND DRAINAGE BUT WAS ULTIMATELY RESOLVED AFTER FIBRIN INFUSION."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "95051",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "08/04/2026"
    }
  ]
}