{
  "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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      "report_to_fda": "",
      "manufacturer_contact_t_name": "MRS.",
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          "openfda": {
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          "patient_sex": "Unknown",
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          "patient_race": "",
          "patient_problems": [
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            "Hemorrhage/Blood Loss/Bleeding"
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      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "21337731",
      "removal_correction_number": "",
      "number_devices_in_event": "",
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      "manufacturer_name": "",
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      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "AURIS HEALTH, INC.",
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      "single_use_flag": "N",
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          "mdr_text_key": "363160737",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE PATIENT CODED DURING PROCEDURE, THE PHYSICIAN HAD CONDUCTED 4-BIOPSIES AND ON THE 5TH BIOPSY AN ABNORMAL AMOUNT OF BLOOD WAS COMING THROUGH THE ET TUBE. THE SCOPE AND THE PATIENT INTRODUCER WERE REMOVED AND THEY WERE ABLE TO STABILIZE THE PATIENT IN THE ROOM. THE PATIENT WAS MOVED TO ICU WHERE THEY LATER CODED AND PASSED AWAY. THE PHYSICIAN STATED THAT THE MONARCH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH."
        }
      ],
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    }
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}