Malfunction Events in the US FDA MAUDE Database: How Does Robotic Gynecologic Surgery Compare with Other Specialties?

Area of Science:

• Robotic Surgery
• Surgical Technology
• Patient Safety

Background:

• The da Vinci Surgical System is widely used across various surgical specialties.
• Understanding malfunction events (MEs) is crucial for improving patient safety and surgical outcomes.
• The Manufacturer and User Facility Device Experience (MAUDE) database serves as a vital resource for tracking device-related adverse events.

Purpose of the Study:

• To review da Vinci robot malfunction events (MEs) reported to the FDA MAUDE database between 2010 and 2020.
• To compare the characteristics of MEs in gynecologic surgery with those in other surgical specialties.
• To identify the primary causes and consequences of robotic system malfunctions.

Main Methods:

• A retrospective review of 679 da Vinci robot malfunction event reports from the FDA MAUDE database (2010-2020).
• Analysis focused on intraoperative events, causes of malfunction (robotic, instrument, accessory, user error), and impact on procedure completion.
• Comparative analysis between gynecologic surgery and other surgical specialties regarding ME characteristics and patient outcomes.

Main Results:

• Most MEs (81.7%) occurred intraoperatively, predominantly due to robotic instrument malfunction (84.5%), often necessitating an instrument switch (30%).
• Conversion to open or laparoscopic surgery was required in 4.4% of cases. Patient injury occurred in 15.6% of MEs, with 47.4% being Clavien-Dindo grade III+.
• No significant differences were observed in intraoperative issue resolution, robotic completion rates, or patient injury rates between gynecologic and other surgical specialties (p > 0.05).

Conclusions:

• Robotic instrument malfunctions are the leading cause of intraoperative da Vinci system MEs, frequently requiring instrument replacement.
• While most surgeries are completed robotically, conversions to alternative approaches occur in a small percentage of cases.
• Patient injury rates and overall procedural outcomes related to MEs do not differ significantly between gynecologic surgery and other specialties utilizing the da Vinci system.