Image of the ProTack™ 5 mm fixation device

174006

ProTack™ Fixation Device

The ProTack™ fixation device is used to fix prosthetic material and approximate tissue in various endoscopic surgical specialties such as hernia repair.

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Indications, Safety, and WarningsThe ProTack™ fixation device has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects.
Warnings

Verify mechanical and electrical compatibility of devices from different manufacturers prior to using them together in a procedure.

Applying excessive pressure against the nose of the instrument may stall and/or jam the instrument.

PrecautionsAfter the application of the ProTack™ fixation device, always inspect the surgical site carefully to ensure hemostasis. Minor bleeding may be controlled with electrocautery or manual sutures.Contraindications

Do not use the ProTack™ fixation device on tissue(s) which cannot be inspected visually for hemostasis.

A minimum of 4 mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera. If the total distance from the surface of the tissue to the underlying structure(s) is less than 4 mm, or may be compromised to a total distance of less than 4 mm, use of the device is contraindicated.

This device should not be used in tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of helical fasteners in the diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.

Do not use in ischemic or necrotic tissue.

Please refer to the instructions for use for complete contraindication and risk information.

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ProTack™ Fixation Device

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174006

ProTack™ Fixation Device