Compared with manual suturing, the stapler is more convenient for surgical operation and can shorten the surgical operation time. The benefits in the surgical environment are self-evident. Over the past century, the types and functions of staplers have been continuously increased and improved, and sales have also risen sharply. However, these seemingly simple and convenient surgical instruments have "unknowingly" caused tens of thousands of medical accidents. Due to the development of usage habits and the huge interest relationship, people selectively ignore these major safety accidents that have occurred and are still occurring
Since 1988, surgical staplers have been classified as Class I devices as part of the low-risk, "general-purpose manual surgical instruments" specified by the FDA. The loose censorship system has led to stapling devices of uneven quality entering the market and reaching the hands of medical workers. At the same time, device manufacturers have insufficient after-sales training for hospitals, and doctors have different levels, which greatly increases the risk of using such devices.
According to FDA statistics, from January 1, 2011 to March 31, 2018, more than 32,000 malfunctions, more than 9,000 serious injuries, and 366 deaths related to surgical staplers occurred in the equipment. This includes inability to anastomosis and equipment failure, as well as the deformity of the staples in the wound or the reopening of the wound after the anastomosis. In addition, the report also involved some physicians' operating errors, such as selecting the wrong suture size during the anastomosis procedure.
The U.S. Food and Drug Administration (FDA) issued a statement on April 23, 2019, proposing to reclassify surgical staplers as high-risk medical devices and require pre-market review and performance and effect studies on the devices. In the future, all surgical tissue binding equipment may be classified as Class II equipment, which means that pre-marketing review and approval pre-market notification are required.
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