{
  "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": "2026-10-13",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "manufacturer_g1_city": "Santa Clara",
      "manufacturer_contact_address_1": "3410 Central Expressway",
      "manufacturer_contact_pcity": "+1(408)5",
      "event_type": "Injury",
      "report_number": "2955842-2026-35148",
      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "",
      "date_received": "20260810",
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      "pma_pmn_number": "K182371",
      "date_of_event": "20260714",
      "reprocessed_and_reused_flag": "N",
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          "date_received": "20260810",
          "brand_name": "da Vinci SP",
          "generic_name": "VISION SYSTEM CART",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC",
          "manufacturer_d_address_1": "3410 Central Expressway",
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          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
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      "reporter_state_code": "",
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      "suppl_dates_mfr_received": "08/10/2026",
      "mfr_report_type": "",
      "manufacturer_contact_country": "US",
      "date_changed": "20260903",
      "health_professional": "N",
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        {
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          "date_received": "20260810",
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            "da Vinci Instruments and Accessories"
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          "patient_age": "",
          "patient_sex": "Unknown",
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          "patient_problems": [
            "Unspecified Tissue Injury"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260902",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
      "mdr_report_key": "50195325",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260714",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "95051",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "INTUITIVE SURGICAL, INC",
      "adverse_event_flag": "",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "15933838303",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "An Intuitive Field Service Engineer (FSE) was dispatched to the customer site to further investigate the reported event. Based on the field evaluation, this reported event was confirmed. FSE replaced the Integrated ElectroSurgical Unit (IESU) replacement due to C00 c54 c34. The system was tested and verified as ready for use."
        },
        {
          "mdr_text_key": "15433838302",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that during a da Vinci-assisted hysterectomy, after port placement, the system repeatedly displayed Integrated Electrosurgical Unit (IESU) error C-34 when using both monopolar and bipolar energy. An Intuitive Surgical, Inc. (ISI) Technical Support Engineer (TSE) instructed the customer to switch the energy mode to Classic, but the issue persisted. A system power cycle and hard power cycle, as well as power cycling the IESU, did not resolve the issue. The surgeon elected to convert the procedure to laparoscopic surgery, and additional ports were placed during the conversion. The patient tolerated the change, no patient injury was reported, and the patient was discharged."
        }
      ],
      "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": "09/02/2026"
    }
  ]
}