Late last month, the U.S. Food and Drug Administration (FDA) issued a recall of a circular surgical stapler, called Ethicon. The device, which was manufactured by Johnson & Johnson, is considered to be a high-risk Class I recall.
In a statement released by the FDA, they noted how more than 92,000 units are affected by this recall. They pointed out that the device misfired staples on at least two occasions.
In these cases, staples were misfired into the lower and middle rectums of two different patients who were scheduled to only have a resection performed on the upper portion of that organ.
What Caused the Circular Surgical Stapler to Misfire?
Once the devices were more closely examined, it was discovered that they had uncut washers. This defect caused doctors to be unable to properly execute a 360-degree staple line as intended. Staples came out misshapen as well.
FDA investigators were ultimately able to isolate the defect to only certain units. They determined that Johnson & Johnson had changed their manufacturing process starting in March 2018. They continued producing the medical device using the same steps through March 8, 2019. The company then ceased to manufacture the stapler.
Surgical Stapler Could Cause Death
When announcing the recall, the FDA pointed out how surgeons who continued to use the intraluminal circular stapler device put their patients at risk for injury or loss of life. The FDA listed the potential side effects of misfired staples as internal bleeding, leaking closures, sepsis and death.
The FDA reportedly plans to hold a meeting of its advisory committee members at the end of May. It’s then that they hope to discuss whether they should reclassify surgical staplers as Class II devices.
A big problem with medical device recalls is that it’s often not until several people get hurt or die that a product ultimately gets taken off the market.
Those who survive their ordeal often endure a tremendous amount of pain before a device is ultimately removed from the market. In some cases, they’re left with lasting consequences from a procedure that wasn’t able to be completed as intended. An attorney can advise you of your right to sue for damages for your losses and pain and suffering.