{
  "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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      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2955842-2012-00396",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20120828",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
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      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20120911",
      "manufacturer_contact_f_name": "",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120828",
          "brand_name": "DA VINCI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL,INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
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          "lot_number": "",
          "other_id_number": "",
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          "device_evaluated_by_manufacturer": "R",
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          "openfda": {
            "device_name": "Electrosurgical, Cutting & Coagulation & Accessories",
            "medical_specialty_description": "General, Plastic Surgery",
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          }
        }
      ],
      "product_problems": [
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
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          "patient_sequence_number": "1",
          "date_received": "20120828",
          "sequence_number_treatment": [
            "DA VINCI SURGICAL SYSTEM INSTRUMENTS",
            " AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20130123",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2721087",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120803",
      "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": "2993963",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2012, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ONLINE SURVEY FROM AN UNK SOURCE CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFO RECEIVED IS AS FOLLOWS: \"EXPERIENCED COMPLICATIONS. URINARY STRICTURE. HAD TO HAVE 2ND SURGERY\"."
        },
        {
          "mdr_text_key": "10034574",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DUE TO THE LIMITED INFO PROVIDED IN THE SURGERY, INTUITIVE SURGICAL IS UNABLE TO F/U WITH THE REPORTER TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFO IS RECEIVED CONCERNING THE REPORTED EVENT, A F/U MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA."
        },
        {
          "mdr_text_key": "10487711",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "01/23/2013"
    }
  ]
}