What Are the Advantages of medical staplers？

Medical staplers and staples are medical devices that can replace sutures. They can close large wounds or incisions more quickly and cause patients less pain than sutures. They are often used in minimally invasive surgeries. They may also be used to close wounds in areas where the skin is pressed against the bone, and during surgeries to remove organs or reattach parts of internal organs.

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Surgical staplers are usually made of plastic and contain disposable surgical staple cartridges. Staplers come in both reusable and disposable models. They are similar to construction or industrial staplers and are designed to insert and close multiple staples at once.

The device can be used to seal tissue internally during surgery. They are useful in minimally invasive surgery, helping surgeons reduce uncertainty and improve anastomotic performance in general, bariatric, thoracic and colorectal surgery.

Medical staplers have several significant advantages:

◆Fast: The stapler can connect tissues quickly and effectively, reducing surgical time compared to traditional manual suturing.

◆Consistency: The stapler provides a consistent anastomosis, reducing human error and helping to ensure a strong and stable connection.

◆Reduce Bleeding: The use of medical staplers can reduce the risk of bleeding during surgery because they can achieve hemostasis in the tissue while stapling.

◆Reduces the risk of infection: Staplers can reduce the exposure time of the surgical wound, thereby reducing the risk of infection.

◆Suitable for minimally invasive surgeries: For minimally invasive or laparoscopic surgeries, medical staplers are especially useful because they can complete the stapling work in a smaller space.

◆Improve surgical efficiency: The use of staplers can improve the efficiency of surgery, allowing doctors to complete more stapling tasks in a shorter period of time.

The principle of medical stapler is based on the concept of mechanical anastomosis, which completes the connection of tissues through a series of cleverly designed mechanical structures. The following is the working principle of general medical staplers:

●Opening and positioning: At the beginning of the surgery, the doctor will use the stapler to open it and accurately position it on the tissue site that needs to be stapled.

●Clamping the tissue: There are clamps on both sides of the stapler, which are responsible for clamping the tissue and ensuring the stability of the tissue during the anastomosis process.

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●Cutting and hole-forming: Some staplers have cutting blades or hole-forming features to cut or pass through tissue while stapling.

●Staples: A stapler places one or more rows of metal staples (staples) between the tissues. The staples pass through the tissues and connect them tightly together.

●Cut off excess parts: Some staplers also have a scissor function, which is used to cut off excess nail parts to ensure a smooth and neat anastomosis.

The entire process is usually completed by the surgeon by operating the handle or control device of the stapler. The design of medical staplers can vary based on specific surgical needs and site of anastomosis. This mechanical anastomosis method can improve surgical efficiency and reduce surgical time compared with traditional manual suturing.

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  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.

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:

• 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.