Safe use of surgical staplers

The U.S. Food and Drug Administration (FDA) is concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use.

The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler. Some of the most commonly reported problems in these adverse event reports include:

  • opening of the staple line
  • malformation of staples
  • misfiring
  • difficulty in firing
  • failure of the stapler to fire the staple
  • misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).

Stapler and/or staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical interventions, which may lead to other complications, such as:

  • bleeding
  • sepsis
  • fistula formation
  • tearing of internal tissues and organs
  • increased risk of cancer recurrence
  • death.

Recommendations

  • Read and carefully follow the stapler manufacturer’s instructions for use.
  • Have a range of staple sizes available and select the appropriate size cartridge for the tissue type and thickness.
    • If you have difficulty squeezing the handle of the stapler, you may need to select a different size staple.
    • Avoid using the stapler on tissue that is too thick or too thin for the selected staple size, as this could result in staple malformation.
    • Be aware that different companies may use different colour schemes on the cartridges to indicate different staple sizes.
  • Consider other options if the patient’s tissue is edematous, friable (tissue that readily tears, fragments, or bleeds when gently palpated or manipulated), or necrotic, as the staples may be less likely to securely approximate tissue.
  • Be familiar with the structures around the intended staple site.
    • Check that unintended structures, such as urinary bladder, or foreign objects, such as clips, are not in the staple line.
  • Avoid using on large blood vessels, such as the aorta.
  • Avoid clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
  • If a malfunction of the stapler occurs while applying staples across a blood vessel, then clamp or ligate the vessel before releasing the stapler, while the stapler is still closed on the tissue.
  • Check to ensure that the staples are compatible with the stapler.
  • Be aware that there is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when it is clinically necessary or appropriate to do so.