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The ETHICON™ 4000 45mm Staplers and ETHICON™ 3D 45mm Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ETHICON™ 4000 45mm Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses.

The ETHICON™ 4000 45mm Stapler and ETHICON™ 3D 45mm Reloads are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 45mm Staplers and ETHICON™ 3D 45mm Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 45mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions, and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The end effector has a mechanism that enables the distal portion of the anvil to toggle between the straight and curved configurations. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The staplers are packaged without a reload and must be loaded prior to use. The stapler may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The staplers' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

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