Surgical staplers are used to seal and cut tissue with small staples that are similar to those used for paper and an integral knife. Most of us have stapled papers and found that the staple did not properly form to hold the papers together. This also happens during surgery, sometimes with disastrous results. A surgical stapler may appear to be a simple device, but it is actually a complex device that can be easily misapplied.
For example, intraluminal staplers are used to anastomose portions of the bowel from which a section has been removed. If too much tissue is clamped in the stapler’s jaws, if the tissue is not evenly distributed, if insufficient clamping pressure is applied, excessive activation force is experienced, or if the trigger is not fully closed, the anastomosis will fail. Careful microscopic examination of the stapler, recovered staples, excised tissue, and the stapler itself can reveal what caused the stapling failure. With other staplers, improper positioning, tension on the tissue being stapled, as well as those problems mentioned above can cause failure of the staple line. Rarely is a manufacturing defect the cause of the failure. In some cases, a used staple cartridge (or reload in the manufacturing parlance) is reinserted into the stapler and used. Most cartridges have a lockout to prevent reused, but this can be broken through by the application of excessive force. In this case the tissue will be cut but no staples will be applied to seal the cut tissue.
Depending on the tissue being stapled, failure of the staple line can be deadly. For example, staplers are used in nephrectomies to seal and cut the kidney’s blood vessels. If an artery is cut but not properly sealed, the patient can quickly bleed to death from the cut artery, which is directly fed from the aorta. Some linear staplers can become jammed on tissue and may require surgical removal; on an artery, this can be deadly. With an intraluminal stapler, a failed staple line can sometimes be re-anastomsed by excising the failed staple line and re-stapling, provided there is sufficient tissue to do so. Also with anastamoses, an undected, failed staple line can leak bowel contents and cause peritonitis.
While seemly simple devices, surgical staplers are complex. Their instructions for use must be thoroughly understood and followed closely. The surgical team should have a backup plan, should the staple line fail. Should the staple line fail, the stapler, any recovered staples, and any excised tissue should be retained for examination.
Written by: Medical Device Accident Expert Witness | Expert Witness No. 3571