Surgical staplers are commonly used by surgeons as a substitute for sutures for the purpose of closing lacerations or incisions as well as connecting or removing internal organs, such as the lungs or lower intestines. These devices have been used for over 50 years – and have been the subject of more than 41,000 adverse event reports submitted to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.
According to those reports, surgical staplers such as Endo-Surgery Curved Intraluminal Staplers by Johnson & Johnson's Ethicon unit have malfunctioned at least 31,000 times. 9,000 patients have suffered serious injuries, including hemorrhaging and infections – and 366 patients have died. The Ethicon products have been subject to a Class I recall. According to an announcement on the FDA website, a total of 92,496 units, all manufactured and sold between March 2018 and March of 2019, are affected.
A Secret Database?
Shockingly, many more reports of injuries, although reported to the FDA, were not made publicly available until recently. This is due to the publication of an investigative report by Kaiser Health News, which revealed the existence of a “hidden database” that for years allowed medical device manufacturers to file injury and malfunction reports (“alternative summary reporting”) without the knowledge of the public – including members of the medical profession. Incidents involving death were still required to be reported through the MAUDE database, but all other injury and malfunction incident reports could still go through the hidden database.
Doctors Were Unaware
One of the tragic aspects of all of this lies in the fact that physicians and surgeons rely on public records when making their decisions as to whether or not to use a particular device. One case in point is Dr. Douglas Kwazneski, who was interviewed for the KHN report. He had been assisting another surgeon to perform a routine appendectomy and was using a surgical stapler to seal up the incision when the device suddenly locked up. Later, Dr. Kwazneski searched the MAUDE database to find out if other surgeons had experienced similar malfunctions.
He found nothing. However, when he started asking colleagues about it, two-thirds of them said they had had similar experiences with the device or knew of other surgeons who had. When Dr. Kwazeneski found out that the FDA had a secret database, he said, “It seemed like a cover-up.”
How Surgical Staplers Malfunction
Over the past several years, the most commonly-reported malfunctions are:
- staple complications
Corporate trial lawyers hired to defend medical device manufacturers in injury lawsuits often attempt to cast the blame for accidents on “surgeon error.” However, the evidence strongly indicates that surgical stapler defects are either due to manufacturing errors, or the design was faulty to begin with. In either case, the companies that design and manufacture surgical staplers – primarily Ethicon, Covidien, and Medtronic – had a duty to warn patients and doctors when problems with the devices became apparent.