There is so much to worry about when you go in for surgery. You may have been anxious about anesthesia, infection, and surgical complications. You may have worried about whether the operation would be successful. The last thing on your mind, however, was probably your surgical staples. Yet, surgical staplers and staples can cause serious injuries.
In March 2019, the U.S. Food and Drug Administration (FDA) notified healthcare providers about potential problems with surgical staplers and staples. According to the FDA, more than 41,000 medical device reports were received by the agency between January 1, 2011 and March 31, 2018. These reports included 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.
Later in 2019, the FDA issued multiple recalls of Ethicon surgical staplers for insufficient firing and failure to form complete staples.
April 2019 Ethicon Surgical Staple Recall
In April 2019, the FDA issued a Class 1 recall of Echelon Endo-Surgery Intraluminal Staplers, which are used during gastrointestinal surgeries. 92,496 Endo-Surgery Intraluminal Staplers were recalled. These staplers were made between March 6, 2018 and March 6, 2019 and distributed between March 15, 2018 and March 8, 2019.
The recall included:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
The affected Endo-Surgery Intraluminal staplers had products codes of CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, or ECS33A.
These products were recalled because the insufficient firing of the staplers could—and did—cause injuries. At least two patients were seriously injured due to the defective staplers. When these staplers were used on patients undergoing gastrointestinal surgeries, the patients were put at risk of experiencing:
- Anastomotic leaks
- The need for a permanent ostomy bag
- Nutritional and digestive issues for the rest of their lives
- Additional surgeries, antibiotics, and testing
October 2019 Ethicon Surgical Staple Recall
In October 2019, the FDA issued a Class 1 recall of Echelon Flex™ Endopath® staplers. Echelon Flex Endopath staplers are single-patient medical devices that both cut and staple internal tissue. They are often used in:
- Gynecologic surgeries
- Urologic surgeries
- Thoracic surgeries
- Pediatric surgeries
- General surgeries
5,733 Echelon Flex Endopath staplers made between July 18 and August 3, 2019, and distributed between August 1 and September 26, 2019, were included in the FDA’s October 2019 recall. The devices were recalled because one of the device’s components deviated from the specifications and could cause malformed staples. Malformed staples put patients at risk of suffering:
- Longer surgeries
- Postoperative connection leaks
- Hemorrhagic shock
- Additional surgeries
The recall included specific lots of:
- ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
- ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
- ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)
These Ethicon staplers have the following product codes: EC60A, PCEE60A, PLEE60A, and PSEE60A.
As of October 3, 2019, the FDA had received reports of seven injuries and one death from the Ethicon Flex Endopath Staplers included in the October 2019 recall.
Take Action If You Were Hurt by a Defective Ethicon Surgical Stapler
Most people don’t ask what kind of staplers their surgeon uses during surgery. However, your doctor keeps records of everything that was used during your surgery. If you begin to show signs of an Ethicon surgical stapler injury, you should seek immediate medical help and you should ask your doctor what type of staplers were used and the device codes for those staplers. You should also contact an experienced medical device injury lawyer for a free and confidential consultation. The attorneys and staff nurse at Gray and White Law will thoroughly review your claim and provide you with an honest opinion about your case.
If a defective Ethicon stapler caused your injury, we will fight hard to get you the fair recovery you deserve. We will spare no expense in preparing your case and fighting for your recovery of past and future medical costs, lost income, out-of-pocket costs, pain, suffering, and other damages.