{
  "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": {
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  "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": "2955842-2012-00119",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20120316",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20120201",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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        "User facility"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20120802",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120316",
          "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": "No",
          "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": [
        "Appropriate Device Problem Term/Code Not Available"
      ],
      "reporter_state_code": "WA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "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": "20120316",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS, ACCESSORIES & ESU"
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20130109",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2494871",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120215",
      "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": "16726747",
          "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 GYNECOLOGICAL PROCEDURE WAS COMPLETED, THE PHYSICIAN ASSISTANT FOUND THAT THE PATIENT'S PORT INCISIONS EXHIBITED MILD BURNS. NO OTHER INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "10352452",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4)"
        },
        {
          "mdr_text_key": "16995361",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT, HOWEVER, NO OTHER INFORMATION HAS BEEN PROVIDED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED CONCERNING THIS REPORT. WHILE NO ADDITIONAL INFORMATION WAS PROVIDED, INTUITIVE SURGICAL FIELD SERVICE ENGINEERING (FSE) INVESTIGATED A SIMILAR EVENT REPORTED BY THE SITE THAT OCCURRED DURING A SECOND DA VINCI SI PROCEDURE PERFORMED ON THAT SAME DAY. THE FSE INVESTIGATION FOUND THAT THE ISSUE EXPERIENCED BY THE CUSTOMER WAS DUE TO A DEFECTIVE GROUNDING PAD. (REFER TO MEDWATCH REPORT 2955842-2012-00098). INTUITIVE SURGICAL INVESTIGATION HAS SHOWN THAT IT IS POSSIBLE FOR THE ELECTROSURGICAL UNIT (ESU) CURRENT TO PASS THROUGH THE PATIENT SIDE MANIPULATOR ARM TO GROUND, THROUGH THE CANNULA ACCESSORY TO THE PATIENT, IT THE PATIENT IS NOT PROPERLY GROUNDED. AS OF (B)(4) 2012, THE SITE HAS CONTINUED TO USE THE DA VINCI SI SYSTEM AND 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": "01/09/2013"
    }
  ]
}