{
  "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": "HOSPITAL",
      "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": "2955842-2012-00127",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20120323",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20120222",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "User facility",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20120801",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120323",
          "brand_name": "DA VINCI SI 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",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS3000 A6.0P6",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "NAY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "R",
          "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": [
        "Charred"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250827",
      "health_professional": "",
      "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": "20120323",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20130108",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2502606",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120222",
      "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": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "2578523",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT AFTER REMOVING THE CANNULA ACCESSORIES AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED, CHARRING WAS OBSERVED AT ONE OF THE PORT INCISION SITES. NO ADDITIONAL HARM WAS REPORTED."
        },
        {
          "mdr_text_key": "9751899",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THERE WERE NO REPORTED MALFUNCTIONS WITH THE SYSTEM DURING THE SURGICAL PROCEDURE. HOWEVER, INTUITIVE SURGICAL INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENTS TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARMS TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IF THE PATIENT IS NOT PROPERLY GROUNDED. AS OF (B)(4) 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THIS ISSUE AT THIS HOSPITAL."
        }
      ],
      "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": "01/08/2013"
    }
  ]
}