{
  "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_address_1": "",
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      "event_type": "Injury",
      "report_number": "2955842-2014-04493",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20140723",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
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          "serviced_by_3rd_party_flag": "",
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          "brand_name": "DA VINCI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
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          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
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          "model_number": "",
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            "medical_specialty_description": "Gastroenterology, Urology",
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          "date_received": "20140723",
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      "date_report": "20140627",
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      "manufacturer_contact_city": "",
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20140627",
      "manufacturer_name": "",
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      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "Y",
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      "mdr_text": [
        {
          "mdr_text_key": "19584764",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2014, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION FROM A JOURNAL ARTICLE TITLED, DIVERTICULAR DISEASE COMPLICATED WITH COLOVESICAL FISTULA: LAPAROSCOPIC VERSUS ROBOTIC MANAGEMENT. ACCORDING TO THE REPORTED ARTICLE, ALTHOUGH 1 LEAK OCCURRED IN THE ROB GROUP, THIS PATIENT WAS DIVERTED AND DRAINED AT THE TIME OF THE ORIGINAL OPERATION. THIS PATIENT WAS MANAGED CONSERVATIVELY WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT HAD A LOW OUTPUT COLOCUTANEOUS FISTULA AT THE DRAIN SITE THAT RESOLVED SPONTANEOUSLY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT."
        },
        {
          "mdr_text_key": "19820494",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE LEAK EXPERIENCED BY THE PATIENT. THE JOURNAL ARTICLE DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED IN RELATION TO THE REPORTED EVENT. ISI CONTACTED THE AUTHOR OF THIS ARTICLE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE HOSPITAL NAME, DA VINCI SYSTEM, AND SERIAL NUMBER WERE NOT INCLUDED IN THIS ARTICLE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE JOURNAL ARTICLE INDICATED THAT A PATIENT EXPERIENCED AN INTRAOPERATIVE COMPLICATION DURING A DA VINCI PROCEDURE AND WAS TREATED WITH ANTIBIOTICS. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE INJURY OCCURRED TO THE PATIENT."
        }
      ],
      "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": ""
    }
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}