Invited commentary: Mortality associated with the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

Reddy et al provided us with an article titled “Mortality associated with the use of stapler devices and clip appliers: Analysis of the FDA MAUDE database.” Personally, I believe the writers of this work should be commended for its significance and thoroughness. The current sort of work is of the utmost relevance for all surgeons who use staplers and clip applicators, which, at this moment, is all of us. The failure of these instruments is not a trivial problem. This has been examined partially in metabolic and bariatric surgery; nevertheless, according to a recent examination of the Manufacturer and User Facility Device Experience (MAUDE) database on this sort of case between January 1, 2018 and December 31, 2020, stapler malfunction is an extremely uncommon occurrence in bariatric surgeries. Nonetheless, worry over device failure is growing. The Food and Drug Administration issued a final decision to reclassify surgical staplers for internal use (formerly classified as “manual surgical instruments for general use”) based on documented health hazards, including problems linked with device failure/malfunction. The scope of the analysis presented by Reddy et al is broad and represents the extensive proliferation of these devices over the last 2 decades in various specialties extending from 1992 to 2016. Adverse events including death and the type of device failure were reviewed. The methodology used by the authors has inherent limitations, such as the fact that the MAUDE database reporting of events is likely incomplete because it relies on self-reporting; however, the study points to the temporal increase in malfunctions and the possible lack of accountability for device manufacturers, as well as prompting surgeons to consider potential changes in their practices. Surgical staplers and clip applier devices were linked to a total of 75,415 malfunctions, 21,115 injuries, and 676 fatalities. The majority of fatalities occurred postoperatively (N = 516, 76.3%), with infection/sepsis (N = 89, 17.2%) and vascular injuries (N = 110, 21.1%) being the leading causes. Vascular injuries (N = 73, 92.4%; N = 73, 92.7%; N = 79, 11.7%) were the leading cause of intraoperative death. Both intraoperatively (N = 268; 39.6%) and postoperatively (N = 325; 48.2%), there were device failures resulting in mortality. In post hoc root cause analysis, a problem with surgical staplers and clip applier devices was identified as the leading cause of mortality (N = 238; 65.4%). The authors have established a correlation between surgical staplers and clip applicators and an increase in mortality. A priori, one might assume that the results do not necessarily reflect a rise in the fatal complication rate of these devices but rather an increase in their use. However, Reddy et al have conducted a careful linear regression analysis, adjusting for annual surgical volume, which demonstrates a significant increase in device-related mortality. Before making a final decision, any surgeon reading this publication would question if particular devices can be identified; nevertheless, given the study’s approach, this may be impossible. The authors have wisely recommended that all intraoperatively identified malfunctioning devices are retained for study and reporting. I strongly suggest that every surgeon who uses staplers and/or clip applicators read this informative article.