Last month, Kaiser Health News released a startling report that adverse events and malfunctions, which are typically available through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) reporting system, have been hidden within a secondary program that is inaccessible to the public.
The Kaiser Health News report interviewed Dr. Douglas Kwazneski, whose surgical stapler locked up mid-procedure while he was sealing tissue after an appendectomy. He went to the FDA database and found no other reports of surgical staplers malfunctioning, despite nearly two-thirds of surgeons he spoke to who had experienced the same failure in surgery.
He cautiously described his findings to KHN as seeming like a cover-up. Little did he know at the time about an “alternative summary reporting repository” that hides individual accounts of device failure from the public.
FDA to Investigate Surgical Staplers After ‘Hidden’ Report Article
The alt-summary reporting process was implemented within the FDA nearly 20 years ago to help alleviate burdensome paperwork the agency was experiencing in device failure reports. It was intended for “well-known and well-documented” reports to cut down on the time it was taking to document individual reports. Meaning devices that already had complaints lodged against them would be funneled into a simpler system.
The responsibility rested on the manufacturers to be accountable to the documentation of their devices. It allowed manufacturers to submit quarterly or bi-annual reports and basically compile individual reports into one report. KHN found this kind of reporting allowed for one single injury report for as many as 1,175 individual patient injury reports.
Since 2016, there have been over 1.1 million serious injury or malfunction reports funneled into the internal database instead of MAUDE.
Shortly after the KHN article was issued, the FDA said it would hold an advisory meeting on surgical stapler devices and possibly reclassify them. The agency plans to provide additional recommendations to health care providers about the issue.
According to the FDA, some of the most commonly reported problems involving surgical staplers are:
- Opening of the staple line or malformation of staples
- Difficulty in firing
- Failure of the stapler to fire the staple
- Misapplied staples
Surgical stapler complications and side effects include:
- Fistula formation
- Tearing of internal tissues or organs
- Increased risk of cancer recurrence
Many of these complications involved unplanned or additional surgeries.
Over 41,000 Surgical Stapler Complications Reported
The ongoing analysis of surgical staplers and surgical staples has uncovered 41,000 medical device reports from January 1, 2011, to March 31, 2018. Of that number, there were 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.
The FDA said in its letter “we are aware that many more device malfunction reports during this time frame” were submitted as summary reports.
Medtronic, a surgical stapler manufacturer, said its alternative summary reporting exemption ended in mid-2017. Medtronic recordings in the FDA public reports went from 1,000 in 2015, to about 11,000 last year. These skyrocketing numbers may be attributed to the way the FDA has allowed manufacturers to classify device failure reports.
The FDA is considering reclassifying surgical staplers for internal and external use to a Class II medical device during an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. Surgical staplers are currently regulated as a Class I, which does not require premarket submission to the FDA. That means manufacturers can introduce new models based on older ones without conducting studies on their safety.
When the ongoing analysis of the Alternative Summary Reports concludes, the FDA plans to release the results to the public. The FDA will be investigating reports from January 2001 through March 2018, as well as reports received since March 31, 2018.
Surgical Stapler Lawsuit Review
If you or a loved one has been injured by a surgical stapler, you may want to speak with the lawyers at Johnson // Becker. We are actively pursuing surgical stapler complication lawsuits across the county and you may be entitled to financial compensation for your injuries.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386. We would be honored to speak with you and respond promptly to every inquiry we receive.