(Reuters) -The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to its surgical stapler and classified the action as “most serious”. The issue is related to the unit Ethicon Endo-Surgery’s device, ‘Endopath Echelon Vascular White Reload for Advanced Placement Tip’, which […]
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US FDA says J&J’s unit issues correction related to surgical stapler
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(Reuters) -The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to its surgical stapler and classified the action as “most serious”.
The issue is related to the unit Ethicon Endo-Surgery’s device, ‘Endopath Echelon Vascular White Reload for Advanced Placement Tip’, which tends to inadvertently lockout during surgical procedures, the Food and Drug Administration said on its website.
“There has been one reported death and one injury related to this issue,” the agency added.
The part in question is a single-use cartridge that surgeons load into a stapler to cut and close blood vessels or tissue during an operation. This helps control bleeding and close wounds quickly.
However, the FDA said the device may sometimes appear to work but fail to cut or staple tissue during surgery, and could lead to life-threatening bleeding, surgical delays, or death.
A J&J spokesperson said in an email to Reuters that it notified its affected customers through a correction letter in April, and added that it was a voluntary correction, not a product removal.
Ethicon has advised healthcare facilities to review affected batches and ensure operating room personnel are familiar with the device’s instructions for use and lockout mitigation protocols, the FDA said.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shailesh Kuber)