FDA issues emergency alert on surgical stapler reloads after 1 death, 4 injuries
The U.S. Food and Drug Administration (FDA) has issued an early alert about a potentially high-risk issue with medical staplers sold by Intuitive Surgical. The problem, according to the FDA, is limited to the reloads on devices used with the da Vinci Surgical System.
Intuitive Surgical reported instances of incomplete staple line formations, which could result in tissue being surgically cut, exposing blood vessels or causing other incidents of potentially severe bleeding that may require further surgical interventions to mitigate.
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip Stapler and 8 mm SureForm 30 Gray Reloads are intended to be used with a compatible da Vinci system for resection, transection, of vasculature and tissue, and/or creation of anastomoses for a wide variety of procedures.
As of Feb. 23, there has been one death associated with the malfunctioning stapler, along with four serious injuries. The FDA said it’s currently reviewing reports and available information to better understand the problem. For now, the staplers should not be used until alternative reloads are acquired.
The FDA provided the following details to identify the products subject to this early alert.
- Product Name: 8 mm SureForm 30 Gray Reload
- Part Numbers: 48230M-05, 48230M-06
- Unique Device Identifier: 00886874121931
Next steps
Once identified, all the impacted stapler reloads must be quarantined to ensure they are not used for patient care. Intuitive Surgical said it sent all known customers a letter on March 11, urging them to notify appropriate staff to ensure all defective products are located.
This would include tracking down any stapler reloads that have been shared or further distributed to other providers and surgery centers.
Intuitive Surgical recommends using alternative options for patient care needs.
The specific source of the problem was not revealed, as the FDA is still investigating. The agency’s full alert can be found by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.