Dive Brief:
- Johnson & Johnson’s Ethicon unit has corrected disposable surgical stapler cartridges over a fault related to one death and one injury, the Food and Drug Administration said Friday.
- The company wrote to customers in April after learning that devices may activate but not cut or staple tissue. Additional steps are needed to open and remove locked devices from tissue.
- Ethicon designed the stapler to prevent lockout events from harming patients. Still, the FDA said the lockout problem could cause life-threatening hemorrhage, surgical delay and death.
Dive Insight:
Healthcare professionals use the Ethicon staplers to simultaneously cut and staple tissue. The company sells reload cartridges that have staggered rows of staples. Users insert the cartridges into the jaw of the device.
Ethicon saw an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. The increase prompted Ethicon to contact customers and the FDA to add the event to its Class 1 recall database in May. There are 678,526 affected products in commerce, the FDA said.
Ethicon has asked customers to share its Urgent Medical Device Correction letter with all users of the affected devices. The company has provided a link to a video showing what to do if the device has a lockout. Details of how to fix a lockout are already part of the instructions for use.
When a lockout happens, the knife “does not advance far enough to cut, staples remain below the tissue contact surface and a built-in gap between the anvil and staple cartridge face helps prevent vessel injury during clamping and unclamping,” the FDA said.
The risk stems from the potential for the user to be unable to remove the locked device from the tissue. If that happens, potential harms include surgical delay, bleeding, life-threatening hemorrhagic shock and conversion to open therapy, the FDA said.
