Complications after Endoscopy: Electrosurgical Device Injury or Death as Reported to the FDA

Douglas Overbey, MD, Edward Jones, MD, Nicole Townsend, MD, Gregory Stiegmann, MD, Thomas Robinson, MD. University of Colorado

Background: Electrosurgical devices are commonly used during endoscopy and are being increasingly used with complex procedures such as endoscopic mucosal resection and per oral endoscopic myotomy. Despite their widespread use, the complication profiles of various energy tools have not been well described in the literature.

Hypothesis: Our purposes were (1) to describe causes of endoscopic energy-based device complications leading to injury or death; (2) to determine if common mechanisms leading to injury or death can be identified.

Methods: The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database was searched for surgical energy-based device injuries and deaths (code GEI) reported over 20 years (January 1994 to January 1994). Device failures and injuries/deaths were recorded and analyzed.

Results: Four thousand one hundred and fifty individual reports were analyzed, of which 334 were endoscopic cases. One hundred eighty-four (55%) of these utilized monopolar energy, 90 (27%) utilized argon beam coagulation, 47 (14%) utilized radiofrequency ablation and the remaining were bipolar or argon. The most common complication was an energy burn (241 reports, 72% ) followed by bleeding (40 reports, 12%). Thirteen (4%) reports included mention of a fire. Two hundred and ten (63%) mentioned a perforation. These injuries were regarded as a severe injury or death in the majority of cases (248 reports, 74%). With regard to mechanism of injury, 220 (66%) were a result of direct application. Importantly, 120 (36%) events were not recognized until after the operation, with 37 (11%) unrecognized until after discharge.

Conclusion: Electrosurgical devices are commonly used with both upper and lower endoscopy. Surgical energy can cause significant injury and even death. The most common mechanism of injury was direct application resulting in burns with 63% of reports including perforation. It is important to follow these patients closely after their procedure as 11% of injuries were not recognized until after discharge.