Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE

Abstract

The pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from reports pertaining to PlasmaBlade 3.0 and 4.0. A total of 384 medical device reports were identified, from which 424 adverse events were extracted. Of those, 348 (82.1%) were device malfunctions, 53 (12.5%) were patient injuries, and 23 (5.4%) were operator injuries. Device malfunctions were most frequently caused by delaminated coating (110, 25.9%), followed by ignition or fire (56, 13.2%). Operator injury was most frequently caused by thermal injury (19, 4.5%), followed by laceration (4, 0.9%). Pacemakers (22, 57.9%) were the most common devices causing interference. PEAK PlasmaBlade 3.0 and 4.0 have demonstrated utility during surgeries but are associated with adverse events. Interventions that aim to educate physicians on potential risks may help reduce the incidence of complications. Future studies with standardized reporting protocols are warranted.

Keywords:

• Adverse events
• MAUDE
• patient safety
• PlasmaBlade