OptiFix™ Absorbable Fixation System for Hernia Repair

Indications

OptiFix™ AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

This device is not intended for use except as indicated. Do not use this device where homeostasis cannot be verified visually after open application.

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to:

• Fixation in the close vicinity of underlying structures such as nerves, vessels, viscera, cartilage or bone. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, cartilage or bone. For reference, the length of the fastener below the fastener head is 6.5 mm, and the fastener head is another 0.6 mm (total 7.1 mm).
• Fixation of or in proximity to tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of fasteners in the diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.
• Fixation of vascular or neural structures, viscera, cartilage or bone.
• Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is absorbed.

Warnings

Do not use device if the yellow clip is damaged or not in place (see Figure 1). The OptiFix™ AT Absorbable Fixation System with Articulating Technology is intended for Single Use Only – DO NOT RESTERILIZE. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user. Do not use beyond the expiration date on the package. Remove the yellow clip prior to use of device (see Figure 1). Handle and dispose of all packaging materials in accordance with local and federal laws regarding medical waste. OptiFix™ AT Absorbable Fixation System with Articulating Technology Released Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black. As with any implant material the presence of bacterial contamination may enhance bacterial infectivity. Accepted surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds. Users should be familiar with surgical procedures and techniques involving synthetic absorbable materials before employing OptiFix™ AT Absorbable Fixation System with Articulating Technology fasteners for wound closure, as the risk of wound dehiscence may vary with the site of application and the material used. The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. After use, the OptiFix™ AT Absorbable Fixation System with Articulating Technology may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.  

Precautions

Please read all instructions before using the OptiFix™ AT Absorbable Fixation System with Articulating Technology. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical procedures. Consult the medical literature relative to technique, complications and hazards prior to any surgical procedure. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology can be used with most 5 mm trocars. Ensure compatibility by inserting the device into the trocar prior to introduction into the patient. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology needs to be in the straight position to enter and exit the trocar. The device should not be articulated while the distal tip is in the trocar. The OptiFix™ AT Absorbable Fixation System with Articulating Technology should enter and exit the trocar easily without excessive force. The use of too much force could damage the instrument. Counterpressure should be applied on the target area. Avoid placing hand/finger directly over the area where fastener is being deployed to prevent injury. For the OptiFix™ AT Absorbable Fixation System with Articulating Technology, counterpressure should only be applied after the distal articulating tip is in the fully straight or fully articulated and locked position, and in a manner that compresses the distal tip axially against tissue/mesh to avoid potential damage to the distal tip (see Figure 5). Care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue. Insertion of fasteners is possible into some collagenous structures such as ligaments and tendons, but is NOT possible directly into bone or cartilage. This may damage the device and result in compromised fixation strength. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology should always be used in the fully straight position (Figure 2 - Position 1) or fully articulated position (Figure 3 - Position 2). Do not apply counterpressure or deploy fasteners when the device is in between positions 1 and 2. The OptiFix™ AT Absorbable Fixation System with Articulating Technology should always be used when the handle rotation is locked at the 90°, 180° (as shown in Figure 4), 270° or 360° position. For the OptiFix™ AT Absorbable Fixation System with Articulating Technology, care should be taken not to pull the distal tip of the device too far into the trocar when the device is articulated as this can damage the distal tip. If the device locks and cannot be separated from a fastener that has been deployed into mesh and/ or tissue, place a grasper adjacent to the deployed fastener and pull to free the device. If needed, you may use laparoscopic scissors to cut below the fastener head. The remaining portion of the fastener stem left in the mesh/tissue can be removed with graspers. The device should then be discarded and a new device should be used. If the fastener does not deploy properly, remove the device from the patient and test the device in gauze to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into the patient.  

Adverse Reactions

Potential complications with the use of any prosthesis may include, but are not limited to hemorrhage; pain, erosion, edema and erythema at wound site; allergic reaction to poly(L-lactide-co-glycolide); septicemia/infection; hernia recurrence/wound dehiscence.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

1. Preclinical data on file at BD. Results may not correlate to performance in humans.

Indications

OptiFix™ AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

Contraindications

This device is not intended for use except as indicated. Do not use this device where homeostasis cannot be verified visually after open application.

Contraindications associated with laparoscopic and open surgical procedures relative to mesh fixation apply, including but not limited to:

• Fixation in the close vicinity of underlying structures such as nerves, vessels, viscera, cartilage or bone. Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera, cartilage or bone. For reference, the length of the fastener below the fastener head is 6.5 mm, and the fastener head is another 0.6 mm (total 7.1 mm).
• Fixation of or in proximity to tissues that have a direct anatomic relationship to major vascular structures. This would include the deployment of fasteners in the diaphragm in the vicinity of the pericardium, aorta, or inferior vena cava during diaphragmatic hernia repair.
• Fixation of vascular or neural structures, viscera, cartilage or bone.
• Situations with insufficient in-growth of tissue into the mesh over time, which could result in inadequate fixation once the fastener is absorbed.

Warnings

Do not use device if the yellow clip is damaged or not in place (see Figure 1). The OptiFix™ AT Absorbable Fixation System with Articulating Technology is intended for Single Use Only – DO NOT RESTERILIZE. Reuse, reprocessing, resterilization or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the device and may lead to device failure which may result in injury to the patient. Reuse, reprocessing, resterilization or repackaging may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another. Contamination of the device may lead to injury, illness or death of the patient or end user. Do not use beyond the expiration date on the package. Remove the yellow clip prior to use of device (see Figure 1). Handle and dispose of all packaging materials in accordance with local and federal laws regarding medical waste. OptiFix™ AT Absorbable Fixation System with Articulating Technology Released Prior to use, carefully examine package and product to verify neither is damaged and that all seals are intact. Do not use if the foil pouch or package is damaged or open, or if the center of the temperature indicator on the foil pouch is black. As with any implant material the presence of bacterial contamination may enhance bacterial infectivity. Accepted surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds. Users should be familiar with surgical procedures and techniques involving synthetic absorbable materials before employing OptiFix™ AT Absorbable Fixation System with Articulating Technology fasteners for wound closure, as the risk of wound dehiscence may vary with the site of application and the material used. The device may not fixate through prosthetics derived from biologic material such as xenografts and allografts. Prosthetic should be evaluated for compatibility prior to use. After use, the OptiFix™ AT Absorbable Fixation System with Articulating Technology may be a potential biohazard. Handle and dispose of in accordance with any local and federal laws regarding medical waste.  

Precautions

Please read all instructions before using the OptiFix™ AT Absorbable Fixation System with Articulating Technology. Only persons having adequate medical training and familiarity with surgical techniques should perform surgical procedures. Consult the medical literature relative to technique, complications and hazards prior to any surgical procedure. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology can be used with most 5 mm trocars. Ensure compatibility by inserting the device into the trocar prior to introduction into the patient. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology needs to be in the straight position to enter and exit the trocar. The device should not be articulated while the distal tip is in the trocar. The OptiFix™ AT Absorbable Fixation System with Articulating Technology should enter and exit the trocar easily without excessive force. The use of too much force could damage the instrument. Counterpressure should be applied on the target area. Avoid placing hand/finger directly over the area where fastener is being deployed to prevent injury. For the OptiFix™ AT Absorbable Fixation System with Articulating Technology, counterpressure should only be applied after the distal articulating tip is in the fully straight or fully articulated and locked position, and in a manner that compresses the distal tip axially against tissue/mesh to avoid potential damage to the distal tip (see Figure 5). Care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue. Insertion of fasteners is possible into some collagenous structures such as ligaments and tendons, but is NOT possible directly into bone or cartilage. This may damage the device and result in compromised fixation strength. The OptiFix ™ AT Absorbable Fixation System with Articulating Technology should always be used in the fully straight position (Figure 2 - Position 1) or fully articulated position (Figure 3 - Position 2). Do not apply counterpressure or deploy fasteners when the device is in between positions 1 and 2. The OptiFix™ AT Absorbable Fixation System with Articulating Technology should always be used when the handle rotation is locked at the 90°, 180° (as shown in Figure 4), 270° or 360° position. For the OptiFix™ AT Absorbable Fixation System with Articulating Technology, care should be taken not to pull the distal tip of the device too far into the trocar when the device is articulated as this can damage the distal tip. If the device locks and cannot be separated from a fastener that has been deployed into mesh and/ or tissue, place a grasper adjacent to the deployed fastener and pull to free the device. If needed, you may use laparoscopic scissors to cut below the fastener head. The remaining portion of the fastener stem left in the mesh/tissue can be removed with graspers. The device should then be discarded and a new device should be used. If the fastener does not deploy properly, remove the device from the patient and test the device in gauze to ensure proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into the patient.  

Adverse Reactions

Potential complications with the use of any prosthesis may include, but are not limited to hemorrhage; pain, erosion, edema and erythema at wound site; allergic reaction to poly(L-lactide-co-glycolide); septicemia/infection; hernia recurrence/wound dehiscence.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.

1. Preclinical data on file at BD. Results may not correlate to performance in humans.