The U.S. Food and Drug Administration (FDA) has said that between January 2011, and March 2018, it received over 41,000 medical device reports involving surgical staplers and staples for internal use. The surgical staple injury reports included 366 deaths, around 9,000 severe injuries, and 32,000 stapler malfunctions.

Common safety concerns include malformed, defective staples and staple misfiring. Surgical staple injury related to operator error are also frequent, spurring on new product liability and medical malpractice cases.

Surgical staplers are critical instruments for many operating doctors. The devices cut and seal blood vessels and tissue in a variety of invasive surgeries. But if the staplers are used incorrectly or they fail to fire, patients can bleed profusely and risk injury and death. The FDA says surgical stapler malfunctions and surgeon malpractice can cause one or more of the following surgical staple injury:

• Bleeding
• Sepsis
• Internal tissue damage
• Organ perforation
• Increased risk of cancer recurrence
• Wrongful death
  

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Joe Lyon is an experienced Cincinnati, Ohio product liability and medical malpractice attorney reviewing surgical staple injury cases for injured plaintiffs nationwide.

The Lyon Firm is investigating surgical stapler injury cases against Medtronic and Johnson & Johnson. 

Surgical Staple Injury Lawsuits

Surgical staplers are used for both external and internal operations. They can be used externally to close wounds on the scalp or the torso. Surgical staples are helpful in many medical situations because of quick placement, little tissue reaction, a low risk of infection, and a high-tension would closure.

For internal use, surgical staplers are commonly used in gastrointestinal, gynecologic, thoracic, and other surgeries. Uses are varied and can include organ removal, organ and tissue incisions, connection structures, and closing wounds.

However, the FDA has its safety concerns, noted in a letter to healthcare providers, issued in March 2019. The warning aims to assist stapler manufacturers in the labeling process regarding information about specific health risks, device limitations, and directions for stapler use. Currently, surgical staplers for internal use do not require a pre-market submission to the FDA for approval.

The FDA alert follows an alarming number of medical device reports associated with surgical stapler injury and death. Retained instrument lawsuits can be valuable for plaintiffs, and patients can seek compensation.

Surgical Stapler Defects & Lawsuits

Lawsuits have been filed against surgical stapler manufacturers, including Ethicon and Medtronic, due to design defects, manufacturing defects, failures to warn and failures to properly test the device prior to distribution.

Surgical staples are commonly used for gastric bypass surgery, lung surgery, neck surgery, heart surgery, colonostomies, and appendectomies. These are everyday procedures, which is concerning for both doctors and patient safety advocates.

In their recent review, the FDA found 90 percent of surgical staple injury cases are due to staple misfiring, and stapler malfunction. Other noted complications include a separation of suture lines, staplers adhering to patient tissue, and staples not forming correctly. Stapler malfunction and improper use of the devices can lead to severe health risks, including death.

Surgical Staplers Injury

Most patients don’t think modern medical devices and equipment can malfunction or cause injury. But surgical injury and medical device defects are a reality, much to the dismay of safety advocates and injured plaintiffs across the country.

When medical devices fail and injury and death occurs, legal action may be necessary to ensure the removal of defective products and to compensate those who have suffered at the hands of medical device companies and negligent medical staff.

Surgical instruments can cause injury when poorly designed, poorly manufactured, or used incorrectly. Some instruments may even be retained in a patient’s body in rare cases. The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices, though with an easy path for some device companies, many defective medical devices slip through the cracks.

Surgical stapler lawsuits typically follow incidents where patients suffer an injury during surgery, which may include severe bleeding, sepsis, infection, chronic pain, tissue and organ damage or death. Surgical stapler malfunction typically involves staple misfiring, stapler misuse, defective staplers and staple misapplication due to medical staff negligence.

Ethicon Stapler Recall

Patients undergoing surgery assume the medical instruments that surgeons use during operations are effective and have been properly tested. But that is not always the case, as medical device companies often recall defective medical tools, as seen in the most recent surgical stapler recall initiated by Ethicon, a subsidiary of Johnson & Johnson.

Ethicon recalled the ECHELON FLEX™ ENDOPATH® staplers after they were found to fail to completely form staples. The FDA has been concerned with Ethicon surgical staplers for quite some time.

In May, the FDA decided to require a pre-market review of surgical staplers used in internal procedures, due to a poor safety record of surgical staplers. From 2011 to 2018, the FDA received 412 reports of surgical deaths and around 110,000 malfunctions linked to surgical staplers. About a third of the reported device failures were related to malformed staples, the same safety issue that led to the Ethicon surgical stapler recall.

Earlier in 2019, the FDA recalled 92,000 circular staplers in a Class I event, meaning the agency believed the devices had the potential for serious harm or death. Ethicon warned of an “out-of-specification component” that may misform staples. The malformed staples could lead to a range of severe complications, from prolonging operations to death.

Ethicon has asked doctor and surgeons to check their stocks of affected Echelon Flex Endopath staplers. The 60mm staplers are meant to be quarantined and returned to the manufacturer. The poor safety history of surgical staplers makes them one of the top health technology hazards.

The Echelon Flex Endopath staplers are single-use devices that cut and staple internal tissue. The stapler is designed to simultaneously cut and staple tissue back together during surgery. But the misformed staples fail to properly close incisions.

The stapler recall involves an alleged defective component within the jaw of the device, leading to malformed staples. The company has said the stapler design could lead to prolonged surgery, post-op connection leak, hemorrhage, or death. At least seven serious injuries and one death have allegedly been reported to Ethicon.

Last year, the FDA sent a letter to health care providers and hospitals after discovering more than 41,000 medical device reports that describe adverse events and deaths linked to the use of surgical staplers.