Medical device manufacturer, Ethicon, has issued a field safety notice concerning ENDOPATH Endoscopic Linear Cutter Reloads in Sleeve Gastrectomy Procedures. The affected code numbers are ECR60M, ECR60W, ECR60B, ECR60D, ECR60G and ECR60T.
The manufacturer recognizes the criticality of surgeon expertise in pairing tissue type with the appropriate reload to deliver optimal surgical outcomes. As commitment to surgeons and patient safety, the manufacturer want to share some important information about reload selection for Ethicon's ENDOPATH Endoscopic Linear Cutter Reloads as it relates to laparoscopic sleeve gastrectomy procedures.
The manufacturer would like to reinforce the following from the Instructions for Use of Ethicon's ECHELON ENDOPATH and ECHELON FLEX Family of Staplers:
Tissue thickness should be carefully evaluated before firing any stapler. If tissue cannot comfortably compress to the closed staple height listed in the table, or easily compresses to less than the closed staple height listed in the table, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. Selection of the appropriate staple cartridge should be based upon the combined thicknesses of both the tissue and the staple- line reinforcement material.
Because any given stapler reload performance may be stressed at tissue thicknesses that cannot comfortably compress to a reload's closed staple height, moving towards larger staple reloads may improve performance in these thicker gastric tissues. Echelon Black reload was specifically designed to meet the clinical needs for a thicker tissue application.
The manufacturer advises users to share this information with any of the staff involved in laparoscopic sleeve gastrectomy procedures.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 16 September 2014