{
  "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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      "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": "2955842-2015-00705",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20150508",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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        "Company representation"
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      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20150508",
      "manufacturer_contact_f_name": "",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "302438",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20150508",
          "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",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
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            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20150508",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
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          "patient_problems": [
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          ]
        }
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      "distributor_city": "",
      "date_report": "20150413",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "4759636",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20150413",
      "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": "",
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      "mdr_text": [
        {
          "mdr_text_key": "19349488",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY ARTICLE TITLED, ROBOTIC-ASSISTED ABDOMINAL CERCLAGE PLACEMENT DURING PREGNANCY AND ITS CHALLENGES: VIDEO ARTICLE. (MENDERES, ET AL., 2015). WITHIN THE JOURNAL ARTICLE, IT IS STATED THAT, AN INCIDENTAL UTERINE VESSEL INJURY OCCURRED, IN THE SECOND CASE, DURING DEVELOPMENT OF THE AVASCULAR SPACE. THE JOURNAL ARTICLE ALSO STATES, THE HEMOSTASIS WAS IMMEDIATELY ATTAINED BY CLAMPING THE VESSEL WITH THE FENESTRATED GRASPERS. PERMANENT HEMOSTASIS REQUIRED APPLICATION OF THE VASCULAR CLIPS, PROXIMALLY AND DISTALLY ON THE LACERATED ARTERIAL SITE."
        },
        {
          "mdr_text_key": "19708194",
          "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 COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE DATE OF THE SURGICAL PROCEDURE, THE NAME OF THE FACILITY WHERE THE SURGICAL PROCEDURE WAS PERFORMED, AND THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE ARE UNKNOWN AT THIS TIME. ISI HAS ATTEMPTED TO CONTACT ONE OF THE AUTHORS OF THE JOURNAL ARTICLE 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A UTERINE VESSEL INJURY WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN."
        }
      ],
      "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": ""
    }
  ]
}