Surgical staplers for internal use are used to deliver staples to tissues inside the body during surgery for:
Ezisurg Product Page
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.
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.
The basic working principle of the surgical stapler: the working principle of various surgical staplers is the same as that of staplers, that is, two rows of interlaced staples are implanted into the tissue to staple the tissue with double rows of cross staples, which can tightly staple the tissue to prevent leakage; because small blood vessels can pass through the gap of B-shaped staples, they do not affect the blood supply of the suture site and its distal end.
1. The operation is simple and rapid, which greatly shortens the operation time;
Are you interested in learning more about staples used in surgery? Contact us today to secure an expert consultation!
2. The medical stapler is accurate and reliable, which can maintain good blood circulation, promote tissue healing, effectively prevent leakage, and significantly reduced the incidence of anastomotic leakage;
3. It is easy to sew and anastomose the operation field which is narrow and deep;
4. It changes the open suture or anastomosis by hand into closed suture and anastomosis, so as to reduce the risk of contaminating the operation field by using the disposable surgical stapler during the reconstruction of the digestive tract and the closure of bronchial stump;
5. It can be sutured repeatedly to avoid blood supply and tissue necrosis;
6. It makes endoscopic surgery (thoracoscopy, laparoscopy, etc. ) possible. Without the application of various endoscopic linear staplers, video-assisted thoracoscopy and laparoscopic surgery is impossible.
AI real-time tissue recognition: By , 80% of smart staplers will be equipped with multispectral imaging + AI algorithms to automatically identify tissue thickness/blood supply and adjust the stapler pressure, reducing the incidence of anastomotic leakage by 60% (refer to the intestinal AI anastomosis study in Nature BME).
Intraoperative decision support: Giants such as Johnson & Johnson Ethicon are developing smart staplers with built-in surgical video analysis. By comparing a database of 3 million surgeries, they can indicate risks such as "the staple line is less than 1 cm from the edge of the tumor" before firing (data from the FDA digital medical pre-examination document).
Consumables supply chain forecast: Chinese manufacturers such as Midea Medical have tested the frequency/force data of stapler use to reversely predict the composition of hospital DRG diseases, with an error rate of <8% ( Shenzhen Third Hospital Supply Chain Digital Pilot Report).
Fault pre-detection IoT: The next generation of smart staplers will be equipped with vibration sensors, which will warn of motor attenuation one month in advance based on the 5,000-shot life curve (similar to Siemens MRI pre-maintenance technology migration).