Venuta, F; Rendina, EA; De Giacomo, T; Flaishman, I; Guarino, E; Ciccone, AM; Ricci, C (April 1998). "Technique to reduce air leaks after pulmonary lobectomy". European Journal of Cardio-Thoracic Surgery. 13 (4): 361–4. doi: 10.1016/S1010-7940(98)00038-4. PMID 9641332.

medical Environmental considerations in the selection of medical

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 linear stapler is used in abdominal surgery, thoracic surgery, gynaecology, and paediatric surgery. Generally, the stapler is used for anastomosing of organs and tissues. This type of linear stapler is available in wide range of sizes: from 30mm up to 90 mm (effective length of the anastomosis).

Staple Rows

The FDA received over 41,000 individual medical device reports to its public database for surgical staplers and staples for internal use. The reports included 366 deaths, more than 9,000 serious injuries and more than 32,000 malfunctions. Figueroa D, et al. (2013). Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: A randomized controlled trial. DOI:

Surgical Stapling Products | Medtronic

In 2015, Ethicon recalled 6,744 Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads. The devices were used in gynecologic, urologic, thoracic, pediatric and general minimally invasive surgeries. The surgical stapled anastomosis is best known for its ability to significantly decrease operative time and its consistent results. In addition, for elective intestinal surgery, a stapled anastomosis has been shown to have equivalent outcomes when compared to a hand-sewn anastomosis and in some instances a benefit. Performing a right hemicolectomy with a stapled ileocolic anastomosis has a significantly lower leak rate than a hand sutured one ( ).Medtronic. (2018, May). Updated Urgent Field Safety Notice; Covidien Endo GIA Articulating Reloads. Retrieved from https://www.bfarm.de/SharedDocs/Kundeninfos/EN/06/2018/05304-18_kundeninfo_en.pdf?__blob=publicationFile&v=1 Kolesov VI, Kolesov EV, Gurevich IY, Leosko VA (1970). "Vasosuturing apparatuses in surgery of coronary arteries". Med Tekhnika. 6: 24–8. {{ cite journal}}: CS1 maint: multiple names: authors list ( link)

Medical A New Choice in Surgical Stapling | Lexington Medical

Bron T, et al. (2015). Placement of absorbable dermal staples in mammaplasty and abdominoplasty: A 12-month prospective study of 60 patients. DOI: Tovar, E.V. (2017, October 24). Surgical Staplers for Mechanical Suture Anastomosis. Retrieved from https://aischannel.com/society/surgical-staplers-mechanical-suture-anastomosis/ Ritchie AJ, et al. (1989). Staples versus sutures in the closure of scalp wounds: A prospective, double-blind, randomized trial. The FDA sent a letter to health care providers expressing concerns about an increasing number of adverse events associated with surgical staplers and staples for internal use. Surgical staples need to stay in for a few days or up to 21 days (in some cases) before they can be removed.U.S. Food and Drug Administration. (2019, May 16). Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples. Retrieved from https://web.archive.org/web/20210116125553/https://www.fda.gov/medical-devices/medical-device-recalls/ethicon-recalls-circular-staplers-insufficient-firing-and-failure-completely-form-staples Circular staplers are composed of a two-piece system to create an anastomosis (typically end to end) and cut the tissue in the same motion. They are commonly referred to as EEA staplers and come in a variety of sizes: 25, 28, 29, or 31 mm. The system consists of a stapler handle/arm and an anvil. The anvil is secured into one side of the bowel to be anastomosed and secured with a purse-string technique. The handle/arm section is then inserted into the other end and a pin is brought out that connects to the anvil. The two ends are tightened down and the stapler is fired, creating two rows of staples and cutting the tissue on the inside of the staples. The handle/arm and anvil are then removed as once piece. An example of use of this type of stapler would be for a colorectal anastomosis in which the handle/arm would be placed through the anal canal into the rectum and the anvil would be placed in the proximal colon. Typically, these instruments have an indicator to show when the appropriate amount of compression has been achieved on the tissue for creation of the staple line. Once the stapler is removed, the device will have two circular “donuts” of tissue from the anastomosis creation. Surgical staplers were developed in response to concerns about the healing of traditional sutures. Evidence seemed to suggest that sutures were more prone to leaks and separation, although further study indicates that when placed properly, conventional sutures are perfectly safe. However, the development of the surgical stapler also created a number of advantages, including speed, accuracy, and evenness of wound closure, which made the stapler a useful operating room tool. Both stapling and suturing are taught to surgeons, and training about the appropriate settings for each technique is also provided. The FDA held an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate. (The advisory panel reportedly recommended switching the devices to a higher-risk classification with additional safety requirements.) A more recent development, from the 1990s, uses clips instead of staples for some applications; this does not require the staple to penetrate. [2] History [ edit ]