Symmetry Surgical PC-120 Port ClosOR PRO Instructions
- June 9, 2024
- Symmetry Surgical
Table of Contents
Symmetry Surgical PC-120 Port ClosOR PRO
INDICATIONS FOR USE / CLINICAL BENEFITS
The Port ClosOR 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 Port ClosOR PRO™.
- Protect the Port ClosOR™ 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 Port ClosOR™ cannot be clearly determined.
- DO NOT attempt to use the Port ClosOR™ if the stylet 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 Port ClosOR 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 Port ClosOR PRO™. This is not a reference for trocar closure techniques. Open sterile pouch, remove the Port ClosOR PRO™ and place onto sterile field.
Using the Trocar Swabs
- 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 2). Note: Trocar cannula must be fully inserted into the abdominal cavity prior to use of the Trocar CleanOR.
- 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.
- Check the cannula for free passage. If this is not the case, repeat the process.
- Before disposing of the trocar swabs, visually inspect the devices to ensure they are intact and all components have been retrieved.
Using the Port ClosOR PRO™
- Inspect the Port ClosOR™ to ensure that the stylet moves freely in and out with minimal pressure applied to the stylet. Do not attempt to use the needle if the stylet does not return over the sharp end when tension on the stylet is halted (Figure 1).
- Acquire a suture at least 24 inches in length. Press the stylet to expose its notched end which captures and holds the suture. Place the midpoint of the suture into the indentation of the stylet. Release the stylet to retract the suture into the sleeve. Pull the two lengths of suture back along the sleeve towards the handle end of the Port ClosOR™ and hold in place with gentle tension.
- With the trocar still in place, position the Port ClosOR™ between the edge of the skin and port site. Advance the Port ClosOR™ through the subcutaneous tissue and fascia. Under laparoscopic visualization press the stylet to release the suture into the abdominal cavity. Withdraw the device.
- Position the Port ClosOR™ at the opposite edge (180° degree) of the port site and pass it through the subcuta-neous tissue and fascia into the abdominal cavity. Under laparoscopic visualization press the stylet and with the assistance of a 5mm grasping instrument through the secondary port, reload the suture onto the opened notch of the stylet. Release the stylet to retract the suture into the sleeve. Withdraw the Port ClosOR™ to pull the suture through the tissue. Remove the port and tie the suture to approximate the fascia and peritoneum.
- The Port ClosOR PRO™ should be discarded in biohazardous waste as per standard procedure. Carefully place the used needle in a sharps biohazard container.
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.