Endovascular Stapler Complications During Minimally Invasive Nephrectomy: An Updated Review of the FDA MAUDE Database From 2009-2019.

OBJECTIVE

To characterize the rates of endovascular stapler complications during hilar ligation in minimally invasive radical nephrectomy over the last 10 years.

MATERIAL AND METHODS

We reviewed the Food and Drug Administration Manufacturer and User Facility Device Experience database from January 1, 2009 to August 1, 2019. Staplers were categorized according to type, namely Ethicon Inc. endocutters (Johnson & Johnson, New Brunswick NJ); Endo-GIA (Medtronic, Minneapolis MN); and Endo-TA (Medtronic, Minneapolis MN).

RESULTS

There were 383 cases of complications involving staplers, 63% with Ethicon endocutters; 28% with GIA; and 9% with TA. 22 deaths (5.7% of total complications) were attributed to staplers. No deaths or reoperations occurred due to TA staplers. TA staplers were also associated with a reduced incidence of conversion to open as compared to Ethicon and GIA staplers. Apart from one device, manufacturer evaluation of returned devices either showed no abnormalities or attributed fault to improper use of staplers.

DISCUSSION

We characterized stapler complications during a 10-year period for minimally invasive radical nephrectomy. No deaths or reoperations occurred due to TA staplers, perhaps due to cutting and stapling occurring in separate steps. Based on manufacturer evaluation attributing stapling malfunctions to human errors, training of operating room staff on proper use of these devices is critical to prevent potentially significant complications from occurring.