{
  "meta": {
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    "terms": "https://open.fda.gov/terms/",
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          "brand_name": "DA VINCI SI SURGICAL SYSTEM",
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          "date_received": "20140211",
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      "manufacturer_contact_city": "",
      "mdr_report_key": "3622626",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20140113",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "mdr_text": [
        {
          "mdr_text_key": "4135730",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE PATIENT'S RECTUM WAS DAMAGED AND AS A RESULT OF THE INJURY TO THE PATIENT, THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES TO REPAIR AND COMPLETE THE PROCEDURE. REPORTEDLY, THE INJURY TO THE PATIENT WAS DUE TO THE PATIENT'S ANATOMY. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE PATIENT HAD CANCER, WHICH MADE IT DIFFICULT FOR THE SURGEON TO DELINEATE THE SURGICAL PLANES. NO OTHER INFORMATION WAS PROVIDED."
        },
        {
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          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ISI HAS CONTACTED THE HOSPITAL TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S RECTUM WAS DAMAGED DURING A DA VINCI SURGICAL PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT."
        }
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}