Adverse Reactions - Bard OptiFix Instrucciones De Uso

After use, the O
dispose of in accordance with any local and federal laws regarding medical waste.
PRECAUTIONS
1. Please read all instructions before using the O
2. 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.
3. The O F ™ Absorbable Fixation System can be used with most 5 mm trocars. Ensure compatibility by
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inserting the device into the trocar prior to introduction into the patient. The O
System should enter and exit the trocar easily without excessive force. The use of too much force could
damage the instrument.
4. Counterpressure should be applied on the target area. Avoid placing hand/fi nger directly over the area
where fastener is being deployed to prevent injury.
5. Use caution when deploying the O
nerves, or viscera. The intended fi xation site should be assessed to ensure that while the tissue is com-
pressed the total distance from the surface of the tissue to any underlying structures is greater than the
length of the O F
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6. 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
fi xation strength.
7. 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.
8. 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 can be removed with graspers. The device should then be discarded and a new device should
be used.
9. 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 confi rmed, the device may be
reinserted into the patient.

ADVERSE REACTIONS

Adverse reactions and potential complications associated with fi xation devices such as the O
Absorbable Fixation System may include, but are not limited to the following: hemorrhage; pain, edema and
erythema at wound site; allergic reaction to Poly(D, L)-lactide; infection/septicemia; hernia recurrence/wound
dehiscence.
INSTRUCTIONS FOR USE
1. Take the O F ™ Absorbable Fixation System out of the sterile package using sterile technique.
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2. Bring the prosthesis (mesh) or tissue into position. For tissue approximation, be sure that adequate over-
lap of tissue exists.
3. For laparoscopic ventral hernia repair it is recommended to reduce the pneumoperitoneum appropriately
for better abdominal wall compliance and optimal fastener depth penetration.
4. Place the tip of the O
mesh or tissue and apply adequate counterpressure. Different types of mesh may require different
amounts of counterpressure. Adjust angle and counterpressure appropriately.
5. Counterpressure should be applied to ensure the fastener is fully deployed. Compress handpiece actua-
tion lever in a single, complete and uninterrupted stroke to drive an absorbable fastener through the mesh
into the tissue. Keep consistent pressure on the distal tip of the device through the entire stroke. Release
the actuation lever allowing it to return completely to its resting position. After each deployment, each fas-
tener should be visually assessed for proper placement against the mesh or tissue. Repeat this procedure
until all required fasteners are deployed.
6. The fasteners should be placed entirely in tissue and the head of the fastener should be fi rm against the
mesh or tissue in order to achieve the best fi xation performance. If the fastener head is not fl ush in mesh
or tissue, laparoscopic scissors can be used to cut the fastener head off and a grasper can be used to
remove the head of the fastener. Place another fastener in the same vicinity.
7. After successful deployment of all required fasteners, handle and dispose of in accordance with any local
and federal laws regarding medical waste.
STORAGE
Store the O F ™ Absorbable Fixation System in a dry environment at room temperature. Avoid prolonged
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exposure to elevated temperatures. It is for single use only. Do not use if the foil pouch or package is dam-
aged or open, or if the center of the temperature indicator on the foil pouch is black.
F ™ Absorbable Fixation System may be a potential biohazard. Handle and
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F ™ fastener over or in proximity to underlying bone, vessels,
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™ fastener.
F ™ Absorbable Fixation System at the desired location perpendicular to the
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F ™ Absorbable Fixation System.
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F ™ Absorbable Fixation
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F ™
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