BACKGROUND

While minimally invasive surgery (MIS) offers numerous benefits, ensuring patient safety remains paramount. This study examines the critical role of visualization in MIS safety by analyzing visualization-related adverse events reported in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

METHODS

We implemented a systematic search strategy within the MAUDE database using 165 unique three-word search phrases to capture a broad range of visualization challenges encountered during procedures.

RESULTS

Our analysis of over 12,000 MAUDE reports from 2014 to 2024 reveals a concerning prevalence of such challenges in laparoscopic surgery. A striking 72% of these reports were linked to patient injury, highlighting a strong association between suboptimal visualization and adverse outcomes. Further analysis revealed that over half of the specific visualization-related keywords examined were associated with adverse events resulting in patient injury rates exceeding 50%, indicating a high likelihood of harm when these challenges occur. The potential for significant underreporting in MAUDE suggests the true incidence rate could be drastically higher, potentially affecting over 120,000 patients annually. While reports associated with keywords linked to robotic surgery were considerably fewer in number, the proportion of those linked to patient injury was higher in robotic reports, emphasizing the persistent need for vigilance regarding visualization even with advanced surgical platforms.

CONCLUSIONS

These findings underscore the urgent need for a critical reassessment of the current standard of care for visualization in MIS. Further research is crucial to explore potential causal relationships between suboptimal visualization and patient injury and to develop effective strategies to mitigate these risks, ultimately enhancing patient safety and optimizing surgical outcomes.