October 7, 2021
The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal use. In addition, we are announcing new actions we are taking to help ensure the safe use of these devices.
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 color schemes on the cartridges to indicate different staple sizes.
- Consider other options if the patient's tissue is edematous (swollen with fluid), friable (tissue that readily tears, fragments, or bleeds when gently palpated or manipulated), or necrotic (death of tissue), 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 clamping the stapler on delicate tissue, as clamping can still cause injury even if no staples are fired.
- Have methods of blood vessel control in place in the event of stapler failure. Where practical, proximal control of blood vessels is recommended prior to stapling.
- 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.
Since all unique clinical scenarios cannot be captured through general stapler recommendations, these recommendations are intended to supplement, and not replace, good clinical judgement.
Surgical staplers for internal use are specialized prescription devices used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. Surgical staplers and staples for internal use may be indicated for use in a wide range of surgical applications, including but not limited to gastrointestinal, gynecologic, and thoracic surgery. Because of increased use and reliance on surgical staplers and concerns about the increasing number of adverse events associated with surgical staplers and staples for internal use, the FDA issued a letter to health care providers in March 2019. Today, we are providing an update to our previous recommendations and announcing new FDA actions regarding the safe use of surgical staplers.
On April 24, 2019, the FDA issued a draft guidance, which described proposed recommendations to manufacturers of surgical staplers and staples for internal use about information to include in their product labeling. On the same day, the FDA also published a proposed order to reclassify surgical staplers for internal use.
On May 30, 2019, the agency held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss the increased number of adverse events reported to the FDA and whether reclassifying surgical staplers for internal use from Class I to Class II would be appropriate.
The FDA is now finalizing the April 2019 guidance and proposed order. The final order reclassifies surgical staplers for internal use from Class I into Class II. Reclassifying surgical staplers for internal use as a Class II device subjects them to premarket notification and mandatory special controls to help mitigate known risks of the device. The final order does not affect the classification of staples, which are currently regulated as Class II devices. The final guidance will help promote the safe and effective use of surgical staplers and staples for internal use by helping manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device. Comments to the public docket and shared during the FDA's May 2019 public meeting helped inform these actions.
The FDA continues to work with hospitals and professional societies to encourage training and education associated with the use of these devices.
The FDA routinely monitors postmarket performance of marketed devices. We will continue to collect and analyze all available information related to surgical staplers and staples to better understand the risks and benefits. The FDA will keep the public informed as new information becomes available.
REPORTING PROBLEMS TO THE FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with surgical staplers or implantable staples.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).