{
  "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",
    "results": {
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          "generic_name": "SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT",
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          "device_operator": "",
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          "device_availability": "No answer provided",
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            "medical_specialty_description": "Gastroenterology, Urology",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
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      "date_changed": "20250821",
      "health_professional": "N",
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      "patient": [
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          "date_received": "20220503",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "43 YR",
          "patient_sex": "Female",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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        }
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "14282871",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "manufacturer_state": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "290930493",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING A DA VINCI ROBOTIC DEVICE THAT WAS USED DURING A HERNIA REPAIR SURGERY ON (B)(6) 2022. PATIENT STATED SHE SPENT 4+ HOURS IN POST-OP AND THEY COULDN'T KEEP HER BLOOD PRESSURE STABLE. PATIENT SAID SHE KEPT PASSING OUT DUE TO LOSS OF BLOOD AND WAS HAVING INTENSE PAIN AT THE SURGICAL SITE. PATIENT STATED SHE REQUIRED AN EMERGENCY SURGERY TO EVACUATE THE BLOOD AND REATTACH THE MUSCLE THAT WAS DAMAGED DURING THE SURGERY. PATIENT SAID SHE SPENT SEVERAL DAYS IN THE ICU AND CONTINUES TO HAVE PAIN AND SWELLING DUE TO THE UNEXPECTED BLEED THAT OCCURRED AT THE SURGICAL SITE WHERE THE ROBOTIC DEVICE WAS USED. PATIENT SAID SHE IS NOW ANEMIC AND STILL CAN'T BEND OVER OR DO NORMAL DAY-TO-DAY ACTIVITIES AS SHE'S STILL HEALING FROM THE EVENT."
        }
      ],
      "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": ""
    }
  ]
}