Adverse events associated with single-use bronchoscopes: analysis from the MAUDE database

Med Eng Phys. 2025 Dec;146:104443. doi: 10.1016/j.medengphy.2025.104443. Epub 2025 Sep 23.

ABSTRACT

BACKGROUND: Bronchoscopy is an aerosol-generating procedure and associated with a high risk of viral transmission, particularly during the coronavirus disease (COVID-19) pandemic. This circumstance has expedited the adoption of single-use flexible bronchoscopes (SUFBs) due to their potential to mitigate healthcare personnel exposure to SARS-CoV-2 and reduce patient infection risks.

OBJECTIVE: This study aims at analyzing reported adverse events and complications associated with SUFBs, while delineating recommendations for risk mitigation strategies and ensuring patient safety through an examination of data from the Manufacturer and User Facility Device Experience (MAUDE) database.

METHODS: We conducted an evaluation of adverse events related to SUFBs as documented in the FDA MAUDE database from January 1, 2014, to June 30, 2025. All reports were manually reviewed and categorized based on the primary device problem and any associated patient outcomes.

RESULTS: A total of 280 reports were issued regarding SUFBs. Manual review categorized these into 280 primary device-related problems and 286 patient-related outcomes. The primary category of device-related problems predominately pertained to breakage/fracture (85 cases; 30.4 %), and a loss of image/display (57 cases; 20.4 %). Among patient adverse events, the most frequently encountered were foreign bodies and airway obstruction.

CONCLUSION: Our study augments the existing clinical literature and body of knowledge by providing a comprehensive understanding of potential problems related to SUFBs. It underscores the imperative for continuous surveillance and vigilance to ensure the safety and effectiveness of SUFBs.

PMID:41352859 | DOI:10.1016/j.medengphy.2025.104443