{
  "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,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "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": "+1(408)5",
      "event_type": "Injury",
      "report_number": "2955842-2026-35115",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20260816",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20250828",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "+1(408)523-2100",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "Nielson",
      "source_type": [
        "Other",
        "Foreign",
        "Study",
        "Literature"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20260817",
      "manufacturer_contact_f_name": "Izabel",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "452604",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260816",
          "brand_name": "da Vinci Surgical System",
          "generic_name": "da Vinci Surgical System",
          "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": "N/A",
          "catalog_number": "N/A",
          "lot_number": "Unknown",
          "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": [
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "US",
      "date_changed": "20260817",
      "health_professional": "Y",
      "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": "20260816",
          "sequence_number_treatment": [
            "da Vinci Instruments and Accessories"
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Wound Infection",
            "Unspecified Hepatic or Biliary Problem"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260722",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
      "mdr_report_key": "50264519",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260722",
      "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": "15489543894",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "This clinical study article reviewed a total of 44 adult patients who underwent robotic completion cholecystectomy (CC) between August 2020 and March 2025. The article noted the following: One patient with a retained common bile duct stone requiring a postoperative ERCP, one patient with a perihepatic collection treated with antibiotics, and one patient with a wound infection.It was concluded that robotic CC is a safe and technically feasible approach with high success and low complication rates.Intuitive Surgical Inc. (ISI) has made multiple attempts to obtain additional information; however, as of the date of this report, no new information has been obtained."
        },
        {
          "mdr_text_key": "15989543895",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "No investigation could be performed as the article did not provide any specific information regarding the procedure date or da Vinci System identifiers. No image(s) and/or video clip(s) associated with this reported event were reviewed.Median age was 58.5 years (IQR: 43.5 ¿ 73.3) BMI 35 kg/m2.Citation: Stefanova, I., Callahan, R., Giriradder, V. B., Merali, N., Renardson, L., Lam, S., Liau, S.-S., Platt, E., Riga, A., Kumar, R., Worthington, T. R., Frampton, A. E., Lahiri, R. P., Pencavel, T. D., & Ahmad, J. (2025). The final cut: a multi-centre cohort study evaluating outcomes of robotic completion cholecystectomy. Surgical Endoscopy. https://doi.org/10.1007/s00464-025-12044-1."
        }
      ],
      "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": ""
    }
  ]
}