Surgeons rely on many instruments in the operating room to successfully and safely take care of their patients. Many of them use surgical staplers, which are a very common instrument to use during surgery. However, if a surgical stapler misfires or fails to work as intended, the consequences can be catastrophic.
A report outlined the Food and Drug Administration may have made it possible for the manufacturers of surgical staplers to “hide” adverse reports of their devices failing from the public.
An article issued in Kaiser Health News startled the healthcare industry in 2019 when it alleged the Food and Drug Administration has been hiding millions of adverse reports from the public.
A doctor by the name of Douglas Kwazneski was interviewed by Kaiser Health News, as he was the first to break the news about an adverse reporting system embedded within the FDA. He explained the surprise and shock he experienced when his surgical stapler locked up in the midst of a procedure.
Nearly two-thirds of surgeons he spoke to had experienced the same problem with the stapler. Yet when Dr. Kwazneski went to the FDA reporting system, he found no such reports of stapler failure incidents.
“Going into something without data is dangerous,” he said. “If the information exists, we should have access to it.”
This was only the beginning of a much larger problem with the FDA reporting system and medical device failures.
FDA Alternative Reporting
The “alternative summary reporting repository” was where Kwazneski could have found millions of reports on surgical stapler failure. Yet the FDA had these reports embedded within other device failure reports; meaning the user would have no way of accessing or even searching for the correct data.
How did the alternative summary reporting even happen in the first place? It all began nearly 20 years ago and was intended to help cut down on paperwork that was often backlogged with the agency.
It was intended for “well-known and well-documented” reports. Devices that had complaints against them would be carried over into similar reports.
But doctors were unaware of this method of reporting, and many still are today.
Shortly after the initial Kaiser Health News article ran, the FDA acknowledged there are more than 56,000 surgical stapler files that were never disclosed before. These surgical stapler reports occurred and were subsequently quietly reported to the agency between 2011 and 2018.
FDA to address the problem
In March, the FDA addressed a letter to doctors that “many more device malfunction reports” had been reported to the agency that health care physicians were most likely unaware of.
Even as of 2016, in the FDA database called MAUDE, only 100 stapler-related injuries were available to the public. Yet, the alternative summary reporting system had roughly 10,000 reports files away. As such, these nonpublic records were taken into account when looking at the large scope of stapler injuries and provided a total of 110,000 malfunctions and/or injuries between 2011 and 2018.
Surgical staplers are responsible for sealing tissues inside the body. They are mainly used to save time during surgery; they lessen the risk of anesthesia complications. But if something goes wrong, it can be catastrophic for both the patient and the surgeon. For example, Mark Levering of Ohio suffered a severe brain injury after a malfunctioning stapler caused massive bleeding.
According to the FDA, there have been 366 deaths because of surgical staplers. Other complications from faulty staplers include:
- Opening of the staple line or malformation of staples
- Difficulty in firing
- Failure of the stapler to fire the staple
- Misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)
Surgical stapler lawsuit
Fortunately, surgical staplers are no longer eligible to be reported in the alternative summary program. The FDA said it would end the program in 2019. However, if you or someone you know has been injured by a malfunctioning or faulty surgical stapler, you should find a lawyer immediately. Many people have filed lawsuits against the manufacturers of surgical staplers, such as Ethicon (a subsidiary of Johnson & Johnson) or Medtronic.