{
  "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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      "date_added": "20120221",
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          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
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      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2461093",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120119",
      "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": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "20412806",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT 4 HOURS INTO A DA VINCI S PROSTATECTOMY PROCEDURE, IT WAS NOTED BY THE ANESTHESIOLOGIST THAT THE PATIENT'S HEALTH WAS DECLINING. SEVERAL ATTEMPTS BY THE SURGICAL TEAM WERE MADE TO REVERSE THE PATIENT'S CONDITION, HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "20539779",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2010, ISI CONTACTED THE RISK MANAGER AT (B)(6) HOSPITAL AND SHE INDICATED THAT DUE TO HIPPA REGULATIONS, SHE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. HOWEVER, SHE STATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM AND THERE WAS NO MALFUNCTION OF THE SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. AS OF FEBRUARY 17, 2012, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM."
        }
      ],
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      "distributor_name": "",
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}