{
  "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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      "mdr_text": [
        {
          "mdr_text_key": "15513191525",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that during a da Vinci assisted partial nephrectomy, the customer observed lines across the image on the Single Port (SP) endoscope. The procedure lasted for around 3 hours, the image quality progressively degraded and eventually displayed color bars. A system power cycle temporarily restored vision for about 5 minutes before the issue recurred. As the backup endoscope was expired and no replacement was available, the procedure was converted to open surgery because the existing endoscope could not be re-sterilized in time."
        },
        {
          "mdr_text_key": "16013191526",
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          "patient_sequence_number": "0",
          "text": "Intuitive Surgical, Inc. (ISI) did receive a da Vinci product to perform failure analysis. The 0-Degree Firefly Endoscope. The log review identified a self-test failure associated with error codes 48221 (communications error), 48225 (power failure), and 48229 (power warning), which were related to the reported issue. Additional errors were observed but were not related to the complaint. Functional testing, including Quality Assurance Procedure (QAP), Electronic Diagnostic Testing (EDT), stereo calibration, focus, near-far focus, color recognition, Firefly, camera performance, and leak testing, all passed successfully. Visual inspection found no damage or anomalies, including on the manifold membrane."
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    }
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}