Surgical staplers for internal use are used to deliver staples to tissues inside the body during surgery for:
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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:
Yes, the FDA describes problems that have been reported in letters to healthcare providers, issued in March and October , 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, to discuss reclassification of surgical stapler devices for internal use from Class I to Class II.
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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 the FDA issued:
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.
Consumers can report serious adverse events or other problems related to surgical staplers and other medical devices through the FDA's MedWatch Program.
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