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

Area of Science:

• Medical Devices
• Pulmonology
• Infectious Disease Control

Background:

• Bronchoscopy is an aerosol-generating procedure with high viral transmission risk, especially during the COVID-19 pandemic.
• Single-use flexible bronchoscopes (SUFBs) mitigate healthcare worker exposure to SARS-CoV-2 and reduce patient infection risks.

Purpose of the Study:

• Analyze adverse events and complications linked to SUFBs.
• Delineate risk mitigation strategies for SUFB use.
• Ensure patient safety through MAUDE database examination.

Main Methods:

• Evaluated adverse events for SUFBs in the FDA MAUDE database (Jan 2014 - June 2025).
• Manually reviewed and categorized 280 reports based on device problems and patient outcomes.

Main Results:

• 280 device-related problems and 286 patient outcomes reported for SUFBs.
• Predominant device issues: breakage/fracture (30.4%) and loss of image/display (20.4%).
• Most frequent patient adverse events: foreign bodies and airway obstruction.

Conclusions:

• Study enhances understanding of SUFB-related issues.
• Highlights the need for continuous surveillance of SUFB safety and effectiveness.