Staple Line Failure Using the Proximate® 100 mm Linear Cutter

PURPOSE: An incomplete linear staple line that was discovered during the stapling of an ileal pouch alerted us to evaluate potential usage concerns with linear cutters. This study was designed to assess the integrity of the staple line of three different sizes of linear staplers. METHODS: In an animal model three different lengths of linear cutters (Proximate®, Ethicon Endo-Surgery) were used to cross-staple and transect the large bowel of one pig to check for the integrity of the proximal end of the staple line. RESULTS: Cross-stapling and transecting across the pig’s large bowel demonstrated that if the tissue is advanced up to the highest number on the scale of the 100 mm stapling device, insufficient overlap between the proximal end of the staple line and the proximal end of the cut line occur. CONCLUSIONS: Although a more than 100 mm staple line is delivered, the 100 mm cutter may not produce a double-staggered row of staples at the most proximal end of the staple line if the tissue is advanced past the 9.5 cm mark. Ethicon Endo-Surgery has agreed to add indicator markers to the scale label on the instrument to provide the user with additional guidance for tissue placement.