Abstract
Background
Surgical staplers and clip appliers are commonly used and have a potential to malfunction,
which may result in serious injury or death. These events are self-reported to the
Food and Drug Administration and compiled in the Food and Drug Administration’s Manufacturer
and User Facility Device Experience database. This study characterizes mortality related
to surgical stapler and clip applier failure reported in the Food and Drug Administration’s
Manufacturer and User Facility Device Experience database.
Methods
The Food and Drug Administration’s Manufacturer and User Facility Device Experience
database was reviewed between 1992 and 2016 for medical device reports related to
surgical staplers and clip appliers filed under the following product codes: GAG,
FZP, GDO, GDW, KOG, and GCJ. Adverse events including death and the type of device
failure were reviewed. Temporal trends in reported deaths related to device failure
were analyzed and the Healthcare Cost and Utilization Project database was used to
adjust for annual surgical case volume using linear regression analysis.
Results
A total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with
the use of surgical stapler and clip applier devices. Most deaths occurred postoperatively
(N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively
(N = 268, 39.6%) and postoperatively (N = 325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier
device problem was the most common attributed cause of death (N = 238, 65.4%). In the linear regression analysis, there was a significant increase
in the mortality from device failure in the study period after adjusting for annual
surgical volume (P < .01).
Conclusion
Mortality related to the use of surgical staplers and clip appliers is increasing.
Most deaths occurred postoperatively, and an increased awareness of potential life-threatening
complications is warranted when these devices are used.
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Article info
Publication history
Published online: December 21, 2022
Accepted:
November 14,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Elsevier Inc. All rights reserved.
