Symmetry Surgical RSG-14F Suture PassOR PRO Instructions

Symmetry Surgical RSG-14F Suture PassOR PRO

DESCRIPTION

The Suture PassOR PRO is available in three configurations consisting of the following components:
RSG-14F

• (1) Suture PassORT
•  (1) 10/12mm Guide
• (2) Trocar Swabs (5-8mm and 10-12mm)

RSG-14/18F

• (1) Suture PassOR
• (1) 10/12mm Guide
•  (1) 15mm Guide
•  (2) Trocar Swabs (5-8mm and 10-12mm)

RSG-18F-XL

•  (1) Bariatric Suture PassOR
• (1) 10/12mm XL Guide
• (1) 15mm XL Guide
• (2) Trocar Swabs (5-8mm and 10-12mm)

INDICATIONS FOR USE / CLINICAL BENEFITS

The Suture PassOR PRO is indicated to be used during endoscopic and laparoscopic surgery to keep trocar valves free of debris and facilitate the placement of sutures for secure closure of trocar sites as determined by a licensed physician familiar with the possible side effects, typical finding, limitations, indications or contraindications of performing such procedure.
The pre-assembled device minimizes complications and costs associated with post-operative port site hernia, by facilitating fast and complete peritoneal/fascial closure. The Trocar CleanOR improves endoscopic visualisation and reduces procedure time by enabling clear vision to be maintained.

CONTRAINDICATIONS

This device is not intended for use except as indicated, and when laparoscopic and other minimally invasive surgical techniques are contraindicated.

CAUTIONS / WARNINGS

This device should be used only by surgeons trained in proper techniques for laparoscopic surgery and other minimally invasive procedures.

• Device is sterile if the package is dry, unopened and undamaged. DO NOT use if the pouch is damaged or the packaged seal is broken.
• Verify compatibility. Inspect the endoscope/laparoscope and trocar for sharp edges that could interfere with the components of the Suture PassOR PRO.
• Protect the Suture PassOR with protective sleeve when not in use. Being a needle it can cause injuries.
• DO NOT use in surgical procedures where the position of the Suture PassOR cannot be clearly determined.
• DO NOT attempt to use the Suture PassOR if the plunger is not functioning properly.
• For single patient use only. The design of this device may not perform as intended by the manufacturer if it is reused. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device.
• Improper use of the Trocar CleanOR may lead to patient injuries and / or damage of the endoscope / laparoscope and trocar.
• Trocar swabs should not be inserted on an angle or extended beyond the distal end of the trocar.

INSTRUCTIONS FOR USE

The Suture PassOR PRO has specific indications for use as noted above. In that context, the surgeon is best advised to use a method which his/her own practice and discretion dictates to be best for the patient, consistent with the indications and contraindications outlined above. The following instructions are recommended for the proper function of the Suture PassOR PRO with Guide. This is not a reference for trocar closure techniques. Open sterile pouch, remove the Suture PassOR PRO and place onto sterile field.
Using the Trocar Swabs

1. To remove debris form the trocar valves use the small trocar swab for 5-8mm trocars, and the larger trocar swab for 10-12mm trocars (Figure 1). Note: Trocar cannula must be fully inserted into the abdominal cavity prior to use of the Trocar CleanOR.
2. Select the appropriate trocar swab and insert its foam head into the trocar valve. Advance the trocar swab into the valve, but do not extend the foam head beyond the distal end of the trocar. Move the swab back and forth to absorb any fluid and clean debris from the cannula. Do not release the trocar swab. NOTE: The shafts of the trocar swabs are radiopaque. Trocar CleanOR must be used under direct vision.
3. Check the cannula for free passage. If this is not the case, repeat the process.
4. Before disposing the trocar swabs visually inspect the devices to ensure they are intact and all components have been retrieved.

Using the Suture PassOR

1. Acquire a suture at least 24 inches in length. Remove the needle guard from the Suture PassOR. The arrow indicator mark is aligned with and designates the bevelled side of the needle. Press the plunger on the proximal end of the device to advance the grasper arms past the distal end of the needle. Place the midpoint of the suture between the grasping arms. Release the plunger to retract the suture into the needle. Pull the two lengths of suture back along the needle towards the handle end of the device and hold in place with gentle tension (Figure 2).

2.  Insert the Guide into the trocar wound site and align the holes perpendicular to the trocar wound. Advance the Suture PassOR needle through the Guide and the subcutaneous tissue and fascia (Figure 3). Keep the needlepoint in direct visualization after it has entered the abdominal cavity. Briefly press the plunger to release the suture. Withdraw the device (Figure 4).

3. Position and then push the needle through the opposite side of the Guide, the subcutaneous tissue and fascia. Keep the needlepoint in direct visualization after it has entered the abdominal cavity. Press the plunger to advance the grasping arms. Grasp the previously placed suture loop with the grasping arms (Figure 5). Release the plunger to retract this suture into the needle (Figure 6). Hold one of the two ends of the suture to prevent movement. Withdraw the needle to pull this suture through the tissue. Continue to retract this suture loop until the other end of the suture exits the grasping arms.

4. emove the Guide from the wound site. Using manual traction on the suture withdraw any excess length that may have remained in the abdominal cavity. Use standard technique to tie the suture (Figure 7 and 8).

5. If the 15mm Guide (Figure 9) is used, position the guide with holes 1 and
   2 aligned perpendicular to the trocar wound. Perform the same steps as described above using holes 1 and 2. With another suture, repeat the process using the holes 3 and 4 of the Guide.

6. The Suture PassOR PRO should be discarded in bio-hazardous waste as per standard procedure. Carefully place the used needle in a sharps bio-hazard container after the procedure has been completed.

Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

References

• Minimally Invasive Surgery - Non-Invasive Surgical Instruments - Symmetry Surgical®

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