A Class 1 recall of Ethicon surgical staplers has been issued over a severe and dangerous manufacturing failure. A Class 1 recall is the most serious type of recall and is issued in situations “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the FDA.

Ethicon surgical staplers are used to cut and staple internal tissue during surgery. These sterile medical devices can be used in a variety of surgeries, including both open and minimally-invasive procedures. They are often used for large or complex surgical wounds for which stitches or sutures would be less effective. Unlike these other options, surgical staples do not dissolve, but instead are removed by a doctor after the wound has healed, which can take up to a few weeks.

According to the Miami Herald, Ethicon found that some of its surgical staplers may contain an “out of specification component within the jaw of the device” that can result in malformed staples, which in turn can cause serious complications, such as prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or in the worst cases, even death.

On October 3, 2019, Ethicon sent a letter to customers who purchased the staplers affected in the recall, providing instructions on next steps.

The FDA announced the Class 1 recall a few weeks after Ethicon’s recall letter was sent, noting in its warning about the device recall that “use of these devices may cause serious injuries or death.”

A number of Ethicon surgical staplers have been affected by the recall, including:

• ECHELON Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter (EC60A)
• ECHELON Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter (PCEE60A)
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length (PLEE60A)
• ECHELON Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm Shaft Length (PSEE60A)

In the fall of 2019, Mass Device provided more information on Ethicon’s efforts to deal with the allegedly defective staplers. Reportedly, the issue has affected other countries, not just the U.S. Mass Device explains that it was implemented voluntarily by maker Ethicon, a subsidiary of Johnson & Johnson.

According to Ethicon, less than one percent of the staplers could contain the defective anvil component. The company stated that the defective staplers were distributed in Denmark, the Netherlands, Germany, Luxembourg, Switzerland, and Belgium. Reportedly, the company stopped the production of what they said were the defective lots. They were made between August 1, 2019 and August 15, 2019, says Mass Device.

Moving forward, the company has taken steps to ensure that the problem does not persist, says the news source. This allegedly involved discovering what caused the defect, and finding ways to correct it.

Mass Device also pointed to the stakes of this potential recall, noting that the Emergency Care Research Institute determined that the misuse of surgical staplers topped the charts as the most prevalent health technology hazard.

Almost 110,000 problems with surgical staplers were reported to the FDA between 2011 and 2019. Reportedly, of these 110,000 incidents, 98,404 were malfunctions. Tragically, 11,181 incidents were reported as serious injuries, and 412 of them were patient deaths related to surgical stapler incidents.

According to a report from Kaiser Health News in May 2019, more than half of the reports of surgical staplers malfunctioning were kept secret. Although many incidents of medical device malfunctions are reported to MAUDE, a public FDA database that can be accessed by doctors and patients who may be affected by defective devices, reports of defective Ethicon surgical staplers were kept in a private database.

Doctors and patients argue that hiding these incidents may put people in danger. According to one surgeon, when he searched the FDA’s public database to find out if other doctors had experienced issues using surgical staplers, his results came up empty. However, when he spoke to colleagues about the issue, he found that almost everyone he talked to knew of an incident where a stapler had malfunctioned.

“Going into something without data is dangerous,” he told Kaiser Health News. “If the information exists, we should have access to it.”

In 2020, the ECRI Institute named surgical staplers as one of the top ten potential hazards for hospitals. ECRI is a non-profit that maintains a database of adverse events and device malfunctions at hospitals. Along with other potentially dangerous hazards including cybersecurity breaches, infections, and medication errors, misuse of surgical staplers ranked in the top ten. This ranking is based on the rate at which the defective staplers cause harm to users – both as a result of user error and as a result of device malfunction.

Due to the recalls of Ethicon surgical staplers and the risks of related complications, the FDA has taken serious action. One aspect of the FDA’s actions has been the classification of surgical stapler recalls as Class 1 events. These events are the most serious recall alerts that the FDA can issue and typically indicate that the recalled products are dangerous and potentially deadly.

The approval of surgical staplers may also become stricter due to the widespread recalls of the devices. Earlier this year, an FDA advisory panel endorsed the agency’s proposal to classify surgical staplers as Class II devices. Under this classification, premarket review and other special controls would be established as part of the surgical stapler approval process.

The proposal was supported by professionals from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and even by manufacturers like Medtronic. According to the panel, these proposed regulations would help better ensure that approved surgical staplers are both safe and effective.

In addition to these changes, the panel recommended other changes including simplifying the proposed label changes to the devices and increasing the surgical stapler training provided to surgeons. This could improve outcomes of surgical stapler procedures by preventing user error, such as when a surgeon choses the wrong size of staple for their stapler – a mistake which could have fatal consequences.

As these devices are frequently used in surgeries, a high number of patients may be at risk of experiencing a stapler malfunction. In addition to inherent device defects, malfunctions may also occur when the wrong size of staple is used, or or if the surgeon is not able to see where they are stapling.

This recall of Ethicon surgical staplers is not alone — Ethicon also recalled its circular staplers over possibly not firing sufficiently, or failing to completely form staples.

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