During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.
Doctors commonly use staples over sutures during surgery because they offer several advantages, including:
- Lower risk of infection
- Speed of insertion
- Reduced adverse reaction to surrounding tissue
Two of the major manufacturers of surgical staplers in the United States include Covidien and Ethicon. This blog post will focus on Ethicon’s staplers, in particular those involved in its most recent recalls.
History of Problems with Surgical Staplers
Despite their advantages, widespread use and overall general safety, surgical staplers and staples do not have a perfect operational record. They have caused a variety of problems for patients, including:
- Tissue and organ tearing
- Postoperative connection leak
- Hemorrhagic shock
These problems can be caused by surgical staplers can malfunctioning in several ways:
- Misfiring of the stapler
- The stapler failing to fire
- Improperly formed staples
- The staple line opening
Countdown to Recall
As a result of these problems, various stapler manufacturers have recalled their products and the U.S. Food and Drug Administration (FDA) has made several announcements regarding these issues. Here is a brief timeline of recent events:
March 8, 2019: The FDA issues a letter to health care providers describing the adverse events associated with surgical staplers and staples. The FDA mentions that from January 1, 2011 to March 31, 2018, the FDA received reports that included 366 deaths and more than 9,000 serious injuries.
April 11, 2019: Ethicon issues a recall for circular staplers because they do not fire properly and fail to correctly form staples when fired. The FDA classified this as a Class I recall, the most serious type, as they involve devices that could result in death. This recall applied to approximately 92,496 devices in the United States.
April 23, 2019: The FDA issues draft guidance. This is a proposal for new recommendations for surgical stapler and staple manufacturers requiring they include additional information on product labels.
April 24, 2019: The FDA issues a proposed order to change surgical staplers and staples for internal use from Class I medical devices to Class II medical devices. This change, if adopted, would allow the FDA to implement special controls to make the products safer.
May 30, 2019: The FDA holds an open meeting to discuss reclassifying internal surgical staplers and staples from Class I to Class II medical devices.
October 3, 2019: Ethicon issues a recall for Echelon Flex Endopath Staplers due to their failure to properly form staples. The FDA classified this as a Class I recall. More than 5,700 devices in the United States were subject to this recall.
Ethicon’s Most Recent Recall from October 3, 2019
Ethicon’s October 3, 2019 recall involved one product line, the Echelon Endopath staplers. Specifically, they involved the following products:
- Product code: EC60A – Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
- Product code: PCEE60A – Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
- Product code: PLEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 44cm Shaft Length
- Product code: PSEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 34cm Shaft Length
The lot numbers, as well as additional information concerning the identification of the specific products being recalled, can be found on the FDA’s Medical Device Recall website.
These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.
Litigation Involving Ethicon Staplers
Some litigation has begun and it is ongoing. Concerning the products recalled by Ethicon on April 11, 2019, some individual lawsuits have begun, but are currently in the pre-trial stages of litigation.
As for the products recalled on October 3, 2019, there are few, if any, current lawsuits against Ethicon and Johnson & Johnson, Ethicon’s parent company. If there are any changes, I’ll be sure to let you know in an updated blog post.
Note: The information and images contained in this post were derived from FDA content and news sources.