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Article History

Received: 25 April 2026

Accepted: 21 May 2026

First Online: 3 June 2026

Declarations

:

: The authors declare no competing interests.

: This study utilized data obtained from the U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, a publicly accessible repository that contains de-identified reports of adverse events involving medical devices submitted by manufacturers, healthcare professionals, and consumers. As the MAUDE database consists of publicly available, anonymized data and does not include identifiable patient information, this study did not involve human subjects as defined by federal regulations. Accordingly, institutional review board (IRB) approval and informed consent were not required for this study. The research was conducted in accordance with applicable ethical standards and relevant guidelines for studies using publicly available, de-identified datasets.

: All authors have been offered the opportunity to read the manuscript and clearly declare and consent for publication after approval.

: Generative AI (ChatGPT-5, OpenAI) was used solely for grammar and spelling correction after the drafting was complete. It was not used for conceptualization, scientific argument, reference identification, or data interpretation. The authors are fully responsible for the content. Additionally, NotebookLM (Google Labs) was used for the generation of the visual abstract, no other figures were AI generated and are solely made by RStudio.