Device Failures and Adverse Events Associated With Rhinolaryngoscopes: Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database.

Abstract

Background: Rhinolaryngoscopes are one of the most widely used tools by otolaryngologists and speech-language pathologists in current clinical practice. However, there is limited data on adverse events associated with or caused by the use of rhinolaryngoscopes.

Objective: In this study, we used the Manufacturer and User Facility Device Experience (MAUDE) database with the aim of providing insights that may assist otolaryngologists in better understanding the limitations of these devices and selecting appropriate procedures for their specific clinical setting.

Methods: We characterized complications associated with the postmarket use of rhinolaryngoscope devices from the US Food and Drug Administration MAUDE database from 2016 through 2023.

Results: A total of 2591 reports were identified, including 2534 device malfunctions, 56 injuries, and 1 death, from 2016 through 2023. The most common device problem with rhinolaryngoscopes was breakage (n=1058 reports, 40.8%), followed by fluid leaks (n=632 reports, 24.4%). The third most common problem was poor image quality (n=467 reports, 18%). Other device issues included contamination or device reprocessing problems (n=127 reports, 4.9%), material deformation or wear (n=125 reports, 4.8%), and device detachment (n=73 reports, 2.8%). Of the 63 reported adverse events, the most common patient-related adverse event was hemorrhage or bleeding, accounting for 18 reports, with the root causes including material deformation or wear, breakage, wrinkled rubber, or improper operation.

Conclusions: Our study offers valuable insights for endoscopists and manufacturers to recognize potential issues and adverse events associated with the use of rhinolaryngoscopes. It emphasizes the need for improving device reliability, training, and procedural protocols to enhance patient safety during diagnostic procedures.