MAXTACK30

Indications, Safety, and WarningsIndicationsThe device is indicated for use in fixation of prosthetic material to soft tissue in minimally invasive ventral and minimally invasive groin hernia repair procedures.The intended purpose of the device is fixation of prosthetic material.Contraindications

The device is not intended for use where prosthetic material fixation is contraindicated.

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

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

Do not use on ischemic or necrotic tissue.

Warnings and precautions

Procedures for minimally invasive endoscopic prosthetic fixation surgery should be performed only by qualified physicians familiar with these techniques.

When instruments and accessories from different manufacturers are employed together in a procedure, verify compatibility prior to initiation of the procedure and ensure that any electrical insulation or grounding is not compromised.

Prior to tack deployment, ensure that the distal end of the shaft is as close to perpendicular as possible to the targeted tissue to facilitate appropriate insertion of the tack. After tack deployment, confirm full insertion of the tack into the mesh and/or tissue. The tack head should be flush with the surface of the material being fixated.

A minimum thickness of tissue over underlying bone, vessels, or viscera is needed for full engagement of the tack. The total distance from the surface of the tissue (including the material to be fixated) to the underlying bone, vessels, or viscera should be carefully evaluated prior to application of the device. Refer to the full instructions for use for tack dimensions.

Tacking into tissues that have a direct anatomic relationship to major vascular structures such as through diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava, could result in critical injury to cardiac tissues or other major vascular structures.

Nonwoven, non-porous, or biologic prosthetic materials may compromise full engagement of the tack. The prosthetic material should be carefully evaluated prior to application.

Appropriate force should be applied with the handle of the device when placing tacks. Excessive force may result in damage to the tissue, the material being fixated, or the device. Inadequate counter pressure may result in partially engaged or broken tacks.

The device should not be used in procedures where soft tissue fixation would not normally be used.

The device should not be used where permanent fixation is desired.

Always inspect the fixation site to ensure hemostasis. Minor bleeding may be controlled with electrocautery or other appropriate methods.

This device is provided sterile for single procedure only. Sterile unless sterile barrier system(s) has been opened or damaged. Visually inspect the packaging and the sterile barrier system before use. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing, and/or resterilization may compromise the structural integrity of the device or may create the risk of contamination, patient infection, permanent impairment, or life-threatening injury.

Depressing the trigger button when not in approximation to mesh and/or tissue will cause the device to deploy a tack, which could potentially fall into the body cavity.

Do not power cycle the device by removing and reinstalling batteries during intraoperative use.

Dispose of the used device along with batteries in accordance with the end-user’s medical and biological waste disposal requirements.

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