{
  "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": "2026-10-13",
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            "medical_specialty_description": "Gastroenterology, Urology",
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      "date_changed": "20260908",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
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      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
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      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "single_use_flag": "N",
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      "mdr_text": [
        {
          "mdr_text_key": "15536680876",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that after a da Vinci-assisted Single Port (SP) radical prostatectomy procedure, the patient developed a hematoma. It was stated the surgery had gone well, and the patient was discharged home from the Post Anesthesia Care Unit (PACU). The hematoma was noted during the patient's follow-up in clinic. There were no allegations against a da Vinci system or instrument. The patient has recovered and is doing fine.Intuitive Surgical Inc. (ISI) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report."
        },
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          "text": "There is no allegation that a malfunction of a da Vinci system, instrument, or accessory occurred. Therefore, there is no indication or evidence that a product issue occurred that meets the criteria of a reportable malfunction."
        }
      ],
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    }
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}