{
  "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": "",
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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": "2955842-2012-00397",
      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20120828",
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      "pma_pmn_number": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20120911",
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      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120828",
          "brand_name": "DA VINCI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL,INC.",
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          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
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            "medical_specialty_description": "Gastroenterology, Urology",
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          }
        }
      ],
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250815",
      "health_professional": "",
      "summary_report_flag": "N",
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        {
          "patient_sequence_number": "1",
          "date_received": "20120828",
          "sequence_number_treatment": [
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            " AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
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      "distributor_city": "",
      "date_report": "20130114",
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      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2721072",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120803",
      "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": "16050486",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2012, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ONLINE SURVEY FROM AN UNK SOURCE CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFO RECEIVED IS AS FOLLOWS: \"THE SCARS WERE MORE PRONOUNCED AND DID NOT HEAL AS WELL AS WITH REGULAR LAPAROSCOPIC SURGERY. IN ADDITION, THE SURGERY CAUSED A SEVERE C-DIFF INFECTION WHICH FORCED ME BACK TO THE HOSPITAL FOR THREE DAYS.\""
        },
        {
          "mdr_text_key": "16326829",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DUE TO THE LIMITED INFO PROVIDED IN THE SURVEY, INTUITIVE SURGICAL IS UNABLE TO FOLLOW UP WITH THE REPORTER TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFO IS RECEIVED CONCERNING THE REPORTED EVENT, A F/U MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA."
        },
        {
          "mdr_text_key": "10391453",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4)."
        }
      ],
      "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": "01/14/2013"
    }
  ]
}