{
  "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": "I",
      "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": "2955842-2017-00142",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "N",
      "date_received": "20170303",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20170220",
      "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": [
        "COMPANY REPRESENTATIVE",
        "FOREIG"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20170303",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "158917",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20170303",
          "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 A60P9B",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "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",
        "Insufficient Device Problem Information"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250804",
      "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": "20170303",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Blood Loss",
            "Blood Loss"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20170220",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6376560",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20170220",
      "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": "69034919",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE VESSEL INJURY SUSTAINED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED COMPLICATION TO THE PULMONARY ARTERY THAT REQUIRED REPAIR. THE VESSEL WAS SEWN. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED DURING THE SURGICAL PROCEDURE."
        },
        {
          "mdr_text_key": "69034920",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE PULMONARY ARTERY. AT THE TIME THE BLEEDING WAS IDENTIFIED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED. WHEN THE EVENT OCCURRED, THE SURGEON WAS ABLE TO CONTROL THE BLEEDING BY USING TACHOSIL SPONGES. THE PULMONARY ARTERY WAS REPORTEDLY SEWN. NO BLOOD TRANSFUSIONS WERE ADMINISTERED. IT WAS NOTED THAT DUE TO THE COMPLEXITY AND LENGTH OF THE SURGICAL PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON REPORTEDLY FELT MORE SECURE COMPLETING THE SURGICAL PROCEDURE VIA OPEN SURGERY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON WAS ABLE TO COMPLETE THE SURGICAL PROCEDURE 10-15 MINUTES AFTER THE CASE WAS CONVERTED TO OPEN SURGERY. IT IS UNCLEAR IF THE SURGEON REPAIRED THE PULMONARY ARTERY BEFORE OR AFTER THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE PATIENT EXPERIENCED AN UNSPECIFIED RESPIRATION ISSUE POST-OPERATIVELY. HOWEVER, IT WAS REPORTED THAT THE RESPIRATION ISSUE WAS UNRELATED TO THE INTRA-OPERATIVELY BLEEDING EXPERIENCED BY THE PATIENT. NO OTHER POST-OPERATIVE COMPLICATIONS WERE REPORTED."
        },
        {
          "mdr_text_key": "72890073",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON 03/19/2017, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION FROM THE SURGEON REGARDING THE REPORTED EVENT: THE ARTERIAL INJURY WAS A TEAR. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED/CONTRIBUTED TO THE INTRA-OPERATIVE BLEEDING OR THE NEED TO CONVERT TO OPEN SURGERY. ACCORDING TO THE SURGEON, THE ROOT CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNKNOWN. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE SURGEON INDICATED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL WITH NO ABNORMALITIES. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED COMPLICATION TO THE PULMONARY ARTERY THAT REQUIRED REPAIR. THE VESSEL WAS SEWN. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS STILL UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY HAD OCCURRED DURING THE SURGICAL PROCEDURE."
        }
      ],
      "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": "03/30/2017"
    }
  ]
}