Johnson & Johnson's Ethicon business confirmed serious device-related injuries of two patients after the Ethicon Endo-Surgery Intraluminal Stapler misfired during a resection of the upper rectum.FDA
Through investigation of complaints and returned products, Johnson & Johnson's Ethicon business confirmed uncut washers in the stapler and malformed staples occur with its intraluminal circular staplers due to insufficient firing, which can compromise staple line integrity. When the washer is cut, confirming completion of the firing cycle, the surgeon experiences an audible and tactile crunch. Failure to cut the washer suggests complete 360-degree staple line failure, FDA noted.
Surgeons use Ethicon Endo-Surgery Intraluminal Staplers in the gastrointestinal tract for creating connections between structures (anastomoses) in surgical procedures. The company confirmed serious device-related injuries to two patients. Misfiring of the stapler resulted in an additional resection (of the middle rectum in one patient and the lower rectum in another patient) during the planned resection of the upper rectum.
A recent investigation detected a shift in the manufacturing process and the line was shut down in early March. The shift in the process had occurred for about a year before the problem was discovered. FDA said using the affected product may cause serious patient harm or death, and the agency identified the recall as a Class I recall, its most serious recall class.
Potential risks to patients include death, sepsis, bleeding, the need for a permanent ostomy bag, life-long nutritional and digestive issues, leak in the closure (anastomotic leak), additional surgeries, need for additional closures (anastomoses), need for antibiotics, and the need for additional imaging studies.
After analyzing more than 41,000 adverse event reports logged between January 2011 and March 31, 2018, FDA found that the most commonly reported problems involve problems with surgical staplers and staples designed for internal use.
The reports include an opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples (for example, the user may have applied staples to the wrong tissue or they may have applied staples of the wrong size to the tissue).
In March 2019, FDA took the following action to better protect patients from malfunctions, injuries, and deaths associated with surgical staplers:
1. Tougher Regulation of Surgical Staplers
FDA proposed reclassifying the staplers into a higher-risk category that requires the review and clearance of a premarket notification submission prior to marketing. Currently, manufacturers of surgical staplers for internal use are not required to submit a premarket notification to the agency because the devices are in the low-risk category, or Class I. The proposed order would bump the devices to Class II (moderate risk) medical devices with special controls, such as mandatory performance testing on various mechanical features, demonstration of usability and labeling comprehension, and specific labeling elements to support safer use of the device.
2. New Labeling Recommendations for Surgical Staplers and Staples
FDA also issued new draft guidance aimed at helping manufacturers ensure their labeling provides adequate information for use, including relevant hazards, contraindications, and other information under which practitioners can use the device safely and for its intended purpose.
The guidance recommends that manufacturers include contraindications for use, such as not using on necrotic (dead) tissue, and warnings, such as avoiding use on large blood vessels. The new guidance also recommends that the directions contain clear instructions, such as how to evaluate staple line formation and integrity and that the product labeling clearly identifies key technical characteristics and performance parameters, such as the types of tissues on which the device may be used.
3. Public Advisory Committee Meeting Scheduled for May 30
FDA has scheduled a public advisory committee meeting for May 30 to receive expert input on the proposed reclassification and draft guidance. As part of the panel meeting, the agency plans to present a comprehensive analysis of all the medical device reports received for surgical staplers for internal use and implantable staples, as well as other relevant information.
These actions are all part of the agency's Medical Device Safety Action Plan, first revealed in April 2018.