Product image of the VersaOne™ bladed trocar

B12LGF

VersaOne™ Bladed Trocar

The VersaOne™ bladed trocar is intended for use in a variety of endoscopic procedures to create and maintain a port of entry.

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Indications, Safety, and WarningsWarnings and precautions

Failure to establish and maintain appropriate pneumoperitoneum in abdominal procedures may reduce available free space, impeding the advancement of the shield and increasing the risk of injury to internal structures.

Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. Medical literature relative to techniques, complications, and hazards should be consulted prior to use.

The VersaOne™ bladed trocar is sharper than reusable trocars and generally requires less force for insertion. Excessive force may reduce the user’s control of the angle and the depth of insertion, which may increase the risk of injury to internal structures.

Adhesions, anatomical anomalies, or other obstructions may prevent or delay the advancement of the shield leaving the linear blade exposed, which may increase the risk of injury to internal structures.

The self-adjusting seal in the VersaOne™ bladed trocar can accommodate instruments ranging from 5 mm to 11 mm in diameter for trocars marked as 11 mm and 5 mm to 12 mm in diameter on trocars marked as 12 mm. Use of instruments less than 5 mm in diameter can result in loss of pneumoperitoneum.

Before and after removal of the VersaOne™ bladed trocar from the abdominal or chest cavity, inspect the site for hemostasis. Bleeding may be controlled by electrocautery or manual sutures. At the surgeon’s discretion, a laparotomy or thoracotomy may be performed.

Do not attempt to insert the trocar if the red flag in the shield indicator does not move from the on to the off position as this indicates that the trocar tip will not be exposed for penetration.

Once entry has been made into free space in the abdominal or chest cavity, care must be taken not to rearm the trocar. If the compression (squeezing) of the handle assembly is stopped and then restarted, the trocar would then be rearmed and the shield will be free to move. Continued advancement of the exposed blade could cause injury to internal structures.

Thoracoscopy is not indicated unless at least a limited intrapleural space exists (air or fluid filled). For this reason, needle aspiration through the selected site is indicated prior to inserting the trocar.

Before endoscopic instruments and accessories from different manufacturers are used together, verify compatibility and ensure that electrical isolation or grounding is not compromised.

A thorough understanding of the principles and techniques involved in laser laparoscopy and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and operator(s), and damage to the instrument.

If the trocar incision is 10 mm or larger, the underlying fascia should be closed, e.g., by suturing to reduce the potential for incisional hernias.

Use care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadvertent damage to the seal.

In abdominal procedures, the incorrect perpendicular trocar insertion could result in an aortic puncture.

This device is provided sterile and is intended for use in a single procedure only. Discard after use. do not resterilize.

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VersaOne™ Bladed Trocar

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VersaOne™ Bladed Trocar