JMIR Publications

ABSTRACT

Background:

Background:

Rhinolaryngoscope is one of the most widely utilized tool routinely employed by otolaryngologists and speech-language pathologists in current clinical practice. However, there is limited data to ascertain association from causation for reported adverse events to the use of rhinolaryngoscope.

Objective:

Objective:

In this study, we used the 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:

Methods:

We characterize post-market complications associated with the use of rhinolaryngoscope devices from the FDA MAUDE database through 2016 to 2023.

Results:

Results:

A total of 2591 reports were identified including 2534 device malfunctions and 56 adverse events in patients from 2016 through 2023. The most common device problem with rhinolaryngoscope was breakage (1058 reports, 40.83%), followed by fluid leak (632 reports, 24.39%). The third common problem was poor image quality (467 reports, 18.02%). Other device issues included contamination or device reprocessing problem (127 reports, 4.9%), material deformation or wear (125 reports, 4.82%), and device detachment (73 reports, 2.82%). Of the 63 reported adverse events, the most common patient-related adverse event was hemorrhage/bleeding accounting for 18 reports, with the root causes including material deformation or worn, breakage, wrinkled rubber or improper operation.

Conclusions:

Conclusions:

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