Medical device manufacturer Ethicon announced a Class 1 recall of a surgical stapler after several injuries and one death were reported due to device malfunction.
Malformed staples could mean problems with the staple line, which if gone unnoticed, increase the risk for prolonged surgery, post-operative connection leaks, bleeding, hemorrhagic shock, additional surgeries, and death.
The Echelon Flex Endopath Stapler is used to cut and staple internal tissue during open and minimally invasive surgeries. The single-use device was recalled because some products contained an out-of-specification component within the jaw of the device that could lead to malformed staples.
The U.S. Food and Drug Administration (FDA) has reported 7 serious injuries and 1 death associated with Ethicon’s failed surgical staplers as of October 3, 2019. The regulatory agency is encouraging healthcare professionals and patients to report adverse events or side effects of the Echelon Flex Endopath Staplers to the FDA.
You can report adverse side effects using this online form or by calling 1-800-332-1088.
The Echelon Flex is used during open or minimally invasive surgeries to cut and staple internal tissues. Patients who have had or may undergo surgery involving staplers for internal use could be exposed to the recalled stapler. Surgeons who have performed or will perform surgeries using staplers for internal use may also be affected by the recall.
In its Oct. 3 recall letter, Ethicon urged healthcare facilities to remove all affected products from their inventory and send them back to the company.
Surgical staplers for internal use carry the risk of potential complications if the device does not function properly. Malfunctions or misuse can result in prolonged surgical procedures or unplanned, additional surgical interventions. This puts patients at increased risk for dangerous complications, including:
In March 2019, the FDA sent a letter to healthcare providers about the safety of surgical staplers in general. The agency said it was “concerned by the increasing number of adverse events associated with surgical staplers and staples for internal use.”
The FDA analyzed adverse event reports submitted between January 2011 and March 2018 and found a total of over 41,000 reports involving patient death, serious injuries, and device malfunctions.
Of the more than 41,000 reports, there were:
Some of the most commonly reported problems in these adverse event reports included: opening of the staple line or malformation of staples, misfiring, difficulty in firing or failure to fire, and misapplied staples.
In response to these alarming reports, the FDA issued recommendations to medical device manufacturers about what to include in their product labeling. The agency also held an open public meeting in May 2019 about potentially reclassifying surgical staplers from Class I to Class II devices. This would impose stricter regulations on the devices.
If you underwent surgery that involved internal staplers and you experienced adverse side effects, you should report your injuries to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Talk to your healthcare provider to see if you can find out which surgical stapler device was used during your surgery. You may have been harmed by the recalled Ethicon Echelon Flex Endopath Stapler.
Even if you’re unsure which device was used during your surgery, you should speak with an attorney to understand your legal options. You may be entitled to financial compensation that can help cover medical expenses and lost wages.
Fill out the form on this page or call 1-800-631-5656 to speak with a member of the Schmidt National Law Group legal team today.