{
  "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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      "report_to_fda": "",
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      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20130311",
      "manufacturer_contact_f_name": "",
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      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "102173",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20130311",
          "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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
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          "device_evaluated_by_manufacturer": "",
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "product_problems": [
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      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250827",
      "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": "20130311",
          "sequence_number_treatment": [
            "DAVINCI S SYSTEMS, ESU, INSTRUMENT AND ACCESSORIE"
          ],
          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Pain",
            "Injury",
            "Abdominal Distention"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20121219",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2997910",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20121219",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "3131971",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2012, ISI RECEIVED A LEGAL FILING CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY SURGERY. THE LEGAL FILING ALLEGED THAT THE PATIENT SUSTAINED DAMAGE TO HER UTERUS, 'THE PATIENT CONTINUES TO SUFFER FROM ABDOMINAL PAIN, PELVIC PAIN, DYSPAREUNIA, BLOATING, ABDOMINAL DISTENTION, FATIGUE AND DECREASED ENERGY AND STAMINA. DUE TO THE INJURY SUSTAINED TO HER VAGINAL CUFF AND BOWEL DURING THE DAVINCI ROBOTIC HYSTERECTOMY, PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY. PATIENT HAS SUFFERED THE LOSS OF CONSORTIUM.'"
        },
        {
          "mdr_text_key": "10631341",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THERE WAS NO HOSPITAL NAME/CONTACT INFORMATION PROVIDED FOR THE REPORTED EVENT. THEREFORE, A FOLLOW UP ON THE ALLEGED PATIENT'S CONDITION AND EVENT DESCRIPTION COULD NOT BE MADE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED."
        }
      ],
      "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": ""
    }
  ]
}