Surgical staplers and staples are used both externally and internally.
Removable skin staples are medical devices, used externally to close wounds under high tension, including wounds on the scalp or the trunk of the body.
Surgical staples for internal use are medical devices used to deliver compatible staples to internal tissues during surgery.
Advantages of surgical staples include:
- Quick placement
- Minimal tissue reaction
- Low risk of infection
- Strong wound closure
How are surgical staplers used?
When used with implantable staples, surgical staplers may be used in gastrointestinal, gynecologic, thoracic, and many other surgeries. Examples of these uses include:
- Removing part of an organ (resection)
- Cutting through organs and tissues (transection)
- Creating connections between structures (anastomoses)
Are there problems associated with surgical staplers?
Yes, the FDA describes problems that have been reported in a letter to healthcare providers, issued in March 2019, in which the FDA also provides several recommendations and new FDA actions regarding the safe use of surgical staplers.
As first announced in our March 8, 2019, letter to healthcare providers, the FDA has now issued:
- A draft guidance, “Surgical Staplers and Staples for Internal Use - Labeling Recommendations,” to help manufacturers develop labeling with information about specific risks, limitations, and directions for use of the device.
- A proposed order to reclassify surgical staplers for internal use from Class I to Class II medical devices.
- Currently, surgical staplers for internal use are regulated as Class I medical devices, which do not require a premarket submission to the FDA.
- Classification as a Class II device would allow the FDA to establish mandatory special controls and require premarket notification (510(k)).
- A Federal Register notice formally announcing an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. On May 30, 2019, the committee discussed and made recommendations regarding the proposed reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).
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.