The Stapler That Opened the Line It Closed

Surgical staplers cut and seal tissue in one action. When a stapler malfunctions — misfiring, failing to form staples, or applying the wrong staple size to tissue — or is used on tissue too thick or thin, the staple line can fail, causing bleeding or leakage. FDA found the reporting had understated the problem.

FDA's 2019 review reported more than 41,000 device reports for surgical staplers and implantable staples over 2011–2018, including hundreds of deaths, and moved to reclassify internal-use staplers to a higher-control category. (FDA, 2019.)

1. A surgical stapler is loaded and fired to cut and seal tissue in one action.
2. The device misfires, fails to form staples, or the wrong staple size is used for the tissue thickness.
3. The staple line does not hold.
4. Bleeding or leakage follows, sometimes recognized only after closing.
5. Under-reporting through a summary pathway had masked how often this happened.

>41,000 FDA device reports for surgical staplers / staples, 2011–2018, including 366 deaths, >9,000 serious injuries, >32,000 malfunctions. (FDA, 2019)

A failed staple line. Shown through the stapler and its formed or misformed staples — never the patient.