Medical device and pharmaceutical giant Johnson & Johnson, by way of its subsidiary Ethicon Endo-Surgery, LLC, has initiated a corrective action for certain surgical staplers in Europe, the Middle East, and Africa. The corporation has publicly released a notice indicating that its Intramural Staplers are prone to issues with uncut washers and malformed staples.
Incidence reporting regarding malformed staples and uncut washers has increased, and the issues can result in compromised staple lines, according to Ethicon’s release addressed to operating room supervisors, materials management personnel, and chiefs of surgery. To address the problems, Ethicon has initiated a Field Safety Corrective Action on almost 380 lots of its Intramural Staplers in Europe, the Middle East, and Africa (known collectively as the EMEA region).
“If a problem with the staple line is not adequately addressed or is not recognized, there is a potential risk of postoperative anastomotic leak, gastrointestinal injury, hemorrhage or hemorrhagic shock,” Ethicon said in its release.
Ethicon identified 378 lots of Intramural Staplers affected by the corrective action. The corporation advised that facilities with affected lots return the products and use alternative staplers. The release also states that in cases in which facilities do not have access to alternative products, surgeons and staff need to follow specified safety instructions.
The safety instructions include avoiding partial firings of the staplers, ensuring that tissue thickness is within appropriate range for use of the staplers, and ensuring that donuts and cutting washer transections are complete. In addition, surgeons who cannot use alternative products should always inspect their staple lines for hemostasis, line integrity, and leakage.
Currently, the corrective action is confined to EMEA and has not been extended to the United States.
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