Description

The E-Z CLEAN BLADE by ETHICON, part of Megadyne Medical Products, Inc., is a sophisticated monopolar electrosurgical electrode designed for precision and efficiency in surgical procedures. Its primary function is to conduct radio frequency (RF) current, enabling both cutting and coagulation of soft tissue, making it an essential tool for a wide range of surgical applications.

Key Features

• Non-Stick PTFE Coating: The blade features a non-stick polytetrafluoroethylene (PTFE) coating that significantly reduces eschar build-up. This minimizes cleaning interruptions and allows for smoother, faster procedures. The coating's durability is evident as it resists splitting even at temperatures exceeding 700°F.

• Enhanced Safety: Most of the electrode's length is insulated, providing additional safety during use. It is available in various tip configurations and lengths, including standard and modified blades, needles, blunt needles, ball-ends, and ACE blades. These configurations cater to specific surgical needs, such as minimizing blanching and thermal damage during skin incisions.

• Compatibility: The E-Z CLEAN BLADE is compatible with industry-standard hand- or foot-activated electrosurgical pencils and units (ESU). Some configurations offer additional safety features like a guard or nosecone to protect against thermal burns and provide dielectric protection.

Versatility and Use

The electrode is supplied sterile and is intended for single use, aligning with the high standards required in surgical environments. It is designed to fit seamlessly with MEGADYNE™ and other industry-standard electrosurgical pencils, ensuring broad applicability in various surgical settings.

Packaging and Options

Most electrodes are packaged with 12 per case, while those with nose cone configurations come with 24 per case. The product's design includes both disposable and reusable options, with the reusable E-Z Pen offering a 12-use lifespan, ergonomic design, and a lock-out mechanism for enhanced functionality.

Regulatory Compliance

The E-Z CLEAN BLADE is classified under 21 CFR 878.4400 as a Class II electrosurgical cutting and coagulation device. It is FDA 510(k) cleared, ensuring compliance with regulatory standards and providing healthcare professionals with a reliable and effective surgical tool.