{
  "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": "2955842-2013-04723",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20131030",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K050369",
      "date_of_event": "20131002",
      "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": [
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        "Foreign"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20131030",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "556858",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131030",
          "brand_name": "DA VINCI S 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": "IS2000 A5.1P8",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NAY",
          "device_age_text": "",
          "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"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "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": "20131030",
          "sequence_number_treatment": [
            "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20131006",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3438454",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20131006",
      "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": "22365575",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT; HOWEVER, HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SURGEON. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT HAD SUFFERED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE."
        },
        {
          "mdr_text_key": "21999170",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO A BOWEL PERFORATION. IT IS UNKNOWN AT THIS TIME WHEN THE BOWEL PERFORATION WAS NOTICED. THE PATIENT WAS RECOVERING AT THE HOSPITAL AND IT IS UNKNOWN WHETHER THE PATIENT HAD ANY OTHER COMPLAINTS. THE SURGEON MENTIONED TO THE CLINICAL SALES REPRESENTATIVE (CSR) THAT THE PROBLEM WAS DUE TO THE ASSISTANT. THE CSR DOES NOT HAVE ANY FURTHER CLINICAL INFORMATION AS HE WAS NOT AT THE SITE DURING THE DA VINCI HYSTERECTOMY PROCEDURE. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT; HOWEVER, HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SURGEON. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT HAD SUFFERED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY 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": ""
    }
  ]
}