The US Food and Drug Administration (FDA) has labeled April’s recall of endoscopic and non-endoscopic curved intraluminal staplers with adjustable height staples by Johnson & Johnson unit Ethicon a Class I recall. This is the most severe type of recall the FDA can issue. It is used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The recall involved 92,496 Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Intraluminal Staplers designed to enable the creation of connections between structures in surgical procedures.
Reasons for the Recall
Through investigation of complaints and returned products, Ethicon confirmed uncut washers in the stapler and malformed staples occur with their 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.
Risks Associated With Use
The use of the affected product may cause serious patient harm or death. Ethicon has already confirmed serious injuries in patients. Potential risks to patients include:
- The need for permanent ostomy “bag”
- Life-long nutritional and digestive issues
- A leak in the closure (anastomotic leak)
- Additional surgeries
- The need for additional closures (anastomoses)
- A need for antibiotics, and
- The need for additional imaging studies.
Ask Us About the Recall
More than 41,000 individual medical device reports for surgical staplers and staples from 1 January 2011 to 31 March 2018. Last month’s recall is following the trend of increased adverse events associated with surgical staplers and staples. If you or someone you know has been hurt by the misuse or malfunction of a surgical stapler, you may be owed compensation. Contact us immediately for a free legal evaluation.