{
  "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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      "pma_pmn_number": "K081207",
      "date_of_event": "20090916",
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      "device": [
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          "brand_name": "DA VINCI S SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
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      "date_changed": "20250817",
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          "sequence_number_treatment": [
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            " ACCESSORIES"
          ],
          "sequence_number_outcome": [
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          "patient_age": "48 YR",
          "patient_sex": "",
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      "date_report": "20100207",
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      "mdr_report_key": "1646669",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20100207",
      "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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      "single_use_flag": "",
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      "mdr_text": [
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          "mdr_text_key": "1334670",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE."
        },
        {
          "mdr_text_key": "8662736",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON MARCH 18, 2010, THE SURGEON REPORTED THAT THE PATIENT EXPERIENCED MOTOR WEAKNESS IN HER RIGHT HAND THAT PREVENTED HER FROM OPENING HER HAND. THE SURGEON ALSO REPORTED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM DURING THE PROCEDURE, AND THAT HE BELIEVES THE INJURY TO THE PATIENT'S RADIAL NERVE WAS DUE TO THE PATIENT'S ARM POSITIONING. IN ADDITION, THE SURGEON REPORTED THAT AFTER 3 MONTHS OF OUT-PATIENT PHYSICAL THERAPY THE PATIENT HAS FULLY RECOVERED AND SUSTAINED NO PERMANENT DAMAGE. AS OF MARCH 18, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL."
        }
      ],
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}