Complications associated with energy-based devices during thyroidectomy from 2010-2020

Area of Science:

• Surgical Technology
• Medical Device Safety
• Head and Neck Surgery

Background:

• Electrosurgical instruments like Harmonic Focus, LigaSure, and Thunderbeat are integral to head and neck procedures.
• Thyroidectomy frequently utilizes these devices for tissue dissection and hemostasis.

Purpose of the Study:

• To compare device malfunctions, patient adverse events, operative injuries, and interventions associated with Harmonic, LigaSure, and Thunderbeat during thyroidectomy.

Main Methods:

• Analysis of the US Food and Drug Administration's MAUDE database for adverse events related to Harmonic, LigaSure, and Thunderbeat.
• Data extraction focused on events occurring between January 2005 and August 2020 specifically during thyroidectomy procedures.

Main Results:

• Harmonic Focus accounted for the majority of adverse events (63.5%), with common malfunctions including blade damage.
• LigaSure showed high rates of inappropriate function, while Thunderbeat had issues with tissue or Teflon pad damage.
• Burn injury and incomplete hemostasis were the most frequent adverse events reported across devices, with burn injury being common for Harmonic and LigaSure.

Conclusions:

• Device malfunctions vary among Harmonic, LigaSure, and Thunderbeat, with specific patterns for each.
• Burn injuries and incomplete hemostasis are significant patient safety concerns during thyroidectomy using these devices.
• Enhanced physician education may mitigate adverse events linked to the improper utilization of these electrosurgical instruments.