Device Dossier

Tri-Staple™ 2.0 Curved Tip Intelligent Reload - Surgical staple, non-bioabsorbable

Device Dossier for Tri-Staple™ 2.0 Curved Tip Intelligent Reload - Surgical staple, non-bioabsorbable (Surgical staple, non-bioabsorbable, Class III,…

Intended purpose

The Tri‑Staple™ 2.0 reloads are indicated for use in abdominal and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. The Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue. The intended purpose of the device is transection and resection of tissue, and/or creation of anastomosis.

Functional description

The device places three rows of titanium staples and simultaneously divides the tissue so that three rows of staples are placed on either side of the cut line. The flexible introducer provided with the curved tip reload can be mounted on the curved tip and used to guide the anvil underneath the vessel/tissue that is to be transected.

TGA Public Summary