{
  "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": "",
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      "event_location": "HOSPITAL",
      "report_to_fda": "",
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      "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": "2955842-2012-00097",
      "type_of_report": [
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      ],
      "product_problem_flag": "N",
      "date_received": "20120301",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20120117",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "HEALTH PROFESSIONAL",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_l_name": "",
      "source_type": [
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        "User facility"
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20120302",
      "manufacturer_contact_f_name": "",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120301",
          "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": "Yes",
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          "device_evaluated_by_manufacturer": "R",
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          "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": [
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        "Protective Measures Problem"
      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "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": "20120301",
          "sequence_number_treatment": [
            "DA VINCI SI INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "43 YR",
          "patient_sex": "",
          "patient_weight": "88",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20120131",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2474756",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120131",
      "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": "20235939",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS NOT SECURELY VELCROED TO THE OPERATING TABLE, CAUSING THE PATIENT TO SLIDE. THE SYSTEM CAMERA ARM THAT WAS DOCKED TO THE PATIENT WAS ABLE TO HOLD THE PATIENT ON THE TABLE AND PREVENT THEM FROM FULLY SLIDING OFF. DUE TO THE SLIDING, TEARING OCCURRED AT THE TROCAR PORT INCISION LOCATION. THE TEAR WAS REPAIRED AT THE END OF THE SURGICAL PROCEDURE. NO ADDITIONAL PATIENT HARM WAS REPORTED. AFTER THE EVENT OCCURRED, THE SURGEON INDICATED THAT THE CAMERA ARM WAS DIFFICULT TO MOVE AND FELT LIKE IT WAS PULSATING DURING MANUAL MOVEMENT."
        },
        {
          "mdr_text_key": "20391798",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "INVESTIGATION WAS CONDUCTED BY FIELD SERVICE ENGINEERING, WHO INSPECTED THE SYSTEM. A VISUAL EXAMINATION WAS PERFORMED ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) AND TROCAR MOUND AND NO SIGNS OF FATIGUE OR STRESS WERE FOUND. THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT CART WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. ADDITIONALLY, NO ISSUES WERE OBSERVED WHEN MANIPULATING THE ECM. SYSTEM VERIFICATION TESTS WERE THEN PERFORMED WITH NO ISSUES DETECTED. IT WAS DETERMINED THAT THE DAMAGE TO THE PATIENT'S SKIN WAS CAUSED BY THE SURGICAL STAFF NOT PROPERLY SECURING THE PATIENT TO THE OPERATING ROOM TABLE. AS OF MARCH 1, 2012, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE 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": ""
    }
  ]
}