Surgical Stapler
Problems



Overview





The surgical stapler problems can occur intraoperatively, i.e., during the surgery or post operatively, i.e., after the surgery. The intraoperative problems are most often of technical nature in the form of device malfunction and failure, typically visible in plain sight and therefore addressable on site. The postoperative problems are most often of physiological nature, mostly hidden inside the patient and often associated with grave outcomes.



Problems, Intraoperative





The problems of surgical staplers for internal use may occur intraoperatively, i.e., in the course of surgery, most often in the form of device malfunction or failure with end results often plainly visual to the surgeon. Copernicus Surgical aims to help FDA address through the regulatory oversight the intraoperative, mainly technical problems of the surgical staplers for internal use as outlined below with continued support from Galileo Surgical Innovation.



Problems, Postoperative





Much less frequent but more insidious are the problems of surgical staplers for internal use occurring postoperatively, i.e., within hours to even years after the completion of surgery, often in the form of staple line leaks of organ content or bleeding in the staple line usually with a lot more grave clinical outcome including death. Galileo Surgical Innovation aims to take a leading role in directly addressing the postoperative, mainly clinical problems of the surgical staplers for internal use.​



FDA's assessment of and response to surgical stapler problems



On its website FDA asks:



"Are there problems associated with surgical staplers?"


FDA: Surgical Staplers and Staples

and answers:



"Yes, the FDA describes problems that have been reported in a letter to healthcare providers, issued in March 2019, in which the FDA also provides several recommendations and new FDA actions regarding the safe use of surgical staplers".


FDA: Letter to Healthcare Providers

FDA analyzes problems and concludes:



"FDA is concerned by the recent number of adverse events associated with surgical staplers."

"Of the 109,997 reports received, 412 were submitted as deaths, 11,181 were submitted as serious injuries, and 98,404 were submitted as malfunctions." (referring to the Medical Device Reports reported from January 1, 2011 through December 31, 2018)

"In conclusion, the results indicate that surgical stapler malfunction are not uncommon and may produce adverse outcomes such as conversion to open surgery, bleeding, and morbidity."


FDA: Executive Summary for meeting of General and Plastic Surgery Devices Panel

FDA takes actions*:



+ A draft guidance, “Surgical Staplers and Staples for Internal Use - Labeling Recommendations,” issued April 2019

+ A proposed order to reclassify surgical staplers for internal use from Class I to Class II medical devices, issued April 2019

+ A Federal Register notice for a public meeting of General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

+ The committee made recommendations for reclassification of surgical stapler devices for internal use from Class I to Class II, May 2019

+ A final guidance for the Labeling Recommendations to be published in 2020

* Please see RESOURCES for related links


Resources

FDA finalizes actions*:



+ A final guidance, “Surgical Staplers and Staples for Internal Use - Labeling Recommendations,” issued October 2021

+ A final order to reclassify surgical staplers for internal use from Class I to Class II medical devices, issued October 2021

* Please see RESOURCES for related links


Resources

In related developments:



FDA grants a Breakthrough Device Designation for the first product of Copernicus Surgical in October 2019, a distinction reserved for devices providing for "more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions"

The proposed indications of the first product incudes: "(a) assess the condition of the target tissue (b) assess uniformity of target tissue along an intended staple line and (c) measure a reactionary load from a specified area of target tissue compressed to a specified thickness in thoracic,
bariatric and colorectal surgeries."


Breakthrough Device Program

FDA includes in Safer Technologies Program (STeP) the conventional staplers combined with Tissue Probe product of Copernicus Surgical in March 2022, a distinction reserved for devices "reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program"


Safer Technologies Program

* The products displayed on this website are under development and have not been cleared or approved for marketing by any regulatory agency. The contents of this website may be updated in the future without prior notice.