The U.S. Food and Drug Administration (FDA) is concerned by the large number of adverse events associated with surgical staplers and staples specifically for internal use. We are taking multiple actions to help promote patient safety and reduce the risk of adverse events associated with these devices.
Between January 1, 2011 and March 31, 2018, the FDA received over 41,000 medical device reports related to surgical staplers and staples for internal use, including 366 reported deaths, over 9,000 serious injuries, and over 32,000 malfunctions.
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- A draft guidance, “Surgical Staplers and Staples for Internal Use – Labeling Recommendations,” to help manufacturers develop labeling with information about specific risks,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, which is open for public comment through June 24, 2019.
- A proposed order to reclassify surgical staplers for internal use from Class I to Class II medical devices, which is open for public comment through June 24, 2019.
- 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 will discuss and make recommendations regarding the proposed reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls).
We invite any interested parties to participate in the public panel meeting, either by attending the meeting, presenting at the meeting, or submitting written comments.