Surgical staplers for internal use are used to deliver staples to tissues inside the body during surgery for:
- Removing part of an organ (resection)
- Cutting through and sealing organs and tissues (transection)
- Creating connections between structures (anastomoses)
Surgical staplers and staples for external use are used outside the body to close large wounds or surgical cuts on a patient's skin or scalp.
Advantages of surgical staplers and staples include:
- Quick placement
- Minimal tissue reaction
- Low risk of infection
- Strong wound closure
Are there problems associated with surgical staplers?
Yes, the FDA describes problems that have been reported in letters to healthcare providers, issued in March 2019 and October 2021, in which the FDA also provides several recommendations and new FDA actions regarding the safe use of surgical staplers and staples for internal use. Due to the increased number of adverse events reported to the FDA, the agency held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on May 30, 2019 to discuss reclassification of surgical stapler devices for internal use from Class I to Class II.
To help protect patient safety and reduce the number of malfunctions, injuries, and deaths associated with the use of surgical staplers for internal use, in October 2021 the FDA issued:
- A final order to reclassify surgical staplers for internal use from Class I to Class II medical devices. Classification of surgical staplers from a Class I to a Class II device subjects these devices to the requirement to submit a premarket notification (510(k)) and to mandatory special controls.
- A final guidance, "Surgical Staplers and Staples for Internal Use - Labeling Recommendations," to help manufacturers develop labeling with information about specific risks, limitations, and directions for safe use of the devices.
The FDA continues to monitor the safety profile for surgical staplers and staples. In addition, the FDA continues work with hospitals and professional societies to encourage training and education to support the safe use of these devices.
How can I report a problem with a surgical stapler or staples?
Consumers can report serious adverse events or other problems related to surgical staplers and other medical devices through the FDA's MedWatch Program.
Manufacturers, hospitals, and other user facilities must report deaths, serious illness, and injuries associated with the use of medical devices.