ArticleAnnals of gastroenterology
Device failures and patient-related adverse events with small bowel capsule endoscopy: a 20-year MAUDE database analysis.
Article in Annals of gastroenterology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
5 authors.
Funding
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Abstract
Background: Small bowel capsule endoscopy (SBCE) is a critical tool in the evaluation of small bowel bleeding, detection of small bowel neoplasms and diagnosing Crohn's disease. The object of this study was to examine device failures (DF) and patient-related adverse events (PRAE) in SBCE, including those involving the patency capsule system, using user-generated reports from the US Food and Drug Administration's (FDA) Manufacturer and User facility Device Experience (MAUDE) database. Method: We analyzed post marketing surveillance data for SBCE data for all of the SBCE systems from the FDA's MAUDE database from January 2000 until December 2023. Results: A total of 352 reports were obtained during the study period, pertaining to the following SBCE systems, in descending order of frequency: Pillcam SB Conclusions: Findings from the MAUDE database regarding SBCE devices provide valuable information on DFs and PRAEs. This knowledge can help operators optimize patient selection and reduce patient risk.
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