Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study

Area of Science:

• Robotic Surgery
• Surgical Safety
• Head and Neck Oncology

Background:

• Transoral robotic surgery (TORS) using the da Vinci Surgical system received FDA approval in 2009.
• Existing safety data for TORS primarily comes from clinical trials and high-volume academic centers.
• Comprehensive safety profiles require analysis of real-world adverse event data.

Purpose of the Study:

• To catalog adverse events associated with the da Vinci system in head and neck procedures.
• To analyze safety incident reports from a national database.
• To assess the safety of TORS in comparison to other transoral surgical methods.

Main Methods:

• Searched the FDA MAUDE database for TORS safety incident reports (January 2009 - May 2020).
• Utilized keywords "da Vinci" and "Intuitive Surgical" for the database query.
• Manually screened 3312 medical device records to identify 36 relevant head and neck adverse events.

Main Results:

• Death was the most common adverse event (44% of incidents).
• Perioperative hemorrhage was the leading cause of mortality, not device malfunction.
• The incidence of adverse events was comparable to other transoral ablative surgery techniques.

Conclusions:

• Reported adverse events for TORS with the da Vinci system appear infrequent.
• The safety profile of TORS in head and neck procedures aligns with expectations for transoral surgery.
• Further real-world data analysis is crucial for understanding TORS safety.