Adverse Reactions - Bard SorbaFix Instrucciones De Uso

PRECAUTIONS
1. Please read all instructions before using the S
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 S 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 S
System should enter and exit the trocar easily without excessive force. The use of too much force could
damage the instrument.
4. Counter pressure should be applied on the target area. Avoid placing hand/finger directly over the area where
fastener is being deployed to prevent injury.
5. 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.
6. Avoid excessive trigger force as this may damage the device.
7. If the device locks, remove the device from the patient and lightly tap the trigger forward toward the tip to
release.
8. If the device locks and cannot be separated from a fastener that has been deployed into tissue, you may rotate
the device counter clockwise to free the device. The locked 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 air to ensure
proper fastener deployment. Once proper fastener deployment is confirmed, the device may be reinserted into
the patient.

ADVERSE REACTIONS

Adverse reactions and potential complications associated with fixation devices such as the S
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; septicemia/infection; hernia recurrence/wound dehiscence.
INSTRUCTIONS FOR USE
1. Take the S 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 overlap 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 S
angle) to the mesh or tissue and apply adequate pressure. Different types of mesh may require different
amounts of counterpressure. Adjust angle and counterpressure appropriately.
5. Compress handpiece trigger in a single, complete and uninterrupted stroke to drive an absorbable fastener
through the mesh into the tissue. Keep consistent pressure on the tip of the device through the entire stroke.
Release the trigger allowing it to return completely to its resting position. Repeat this procedure until all required
fasteners are deployed.
6. The device should be considered a sharp during handling and disposal. To minimize exposure of sharp or
unintended fastener delivery, do not actuate the trigger during removal from the trocar.
7. The fasteners should be placed entirely in tissue and the head of the fastener should be firm against the mesh
or tissue in order to achieve the best fixation performance. If the fastener head is not flush in mesh or tissue,
use a grasper to fully seat the fastener by turning the grasper clockwise. If the fastener still does not fully seat,
use a grasper to remove the fastener by turning the grasper counter clockwise and place another fastener in
the same area.
8. Care should be taken to ensure that the prosthesis (mesh) is adequately fixated to the abdominal wall. If
necessary, additional fasteners and/or sutures should be used.
9. After successful deployment of all required fasteners, handle and dispose of in accordance with any local and
federal laws regarding medical waste and sharps disposal requirements to prevent sharps injury.
STORAGE
Store the S
F ™ Absorbable Fixation System at room temperature. Avoid prolonged exposure to elevated
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temperatures. It is for single use only. Do not use if the package is damaged or open.
Do not use if the center of the temperature indicator is black.
Copyright © 2009, 2010, 2013, 2014 C. R. Bard, Inc. All Rights Reserved.
Bard, Davol and SorbaFix are trademarks and/or registered trademarks of C. R. Bard, Inc. or an affiliate.
Contents
Sterile unless package is
damaged or open.
Patents Pending
U.S. Federal law restricts this
only device to sale by or on the order
of a physician.
F ™ Absorbable Fixation System at the desired location perpendicular (90 degree
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F ™ Absorbable Fixation System.
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Absorbable
30
S
ORBA
36 cm / 30 Absorbable Fasteners
36CM
15
S
ORBA
36 cm / 15 Absorbable Fasteners
36CM
F ™ Absorbable Fixation
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F
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F ™ Absorbable Fixation System
IX
F ™ Absorbable Fixation System
IX
™ Absorbable