Description

The Weck® Auto Endo5® ML, crafted by Teleflex Medical, is an advanced surgical instrument designed to enhance precision in minimally invasive procedures. This sterile, disposable device serves as an automatic endoscopic clip applier, specifically engineered for the application of Hem-o-lok™ Medium-Large (ML) non-absorbable polymer ligating clips.

Key Features

• Secure Ligation: Ideal for vessels or tissue structures ranging from 3 mm to 10 mm in diameter, ensuring reliable ligation across various surgical needs.
• Pre-loaded Efficiency: Each device comes pre-loaded with 15 clips, streamlining the surgical process and reducing preparation time.

Design Specifications

• Shaft Dimensions: Features a 5 mm diameter with a 35 cm working length, complemented by a total shaft length of 49 cm.
• Clip Design: The clips boast integrated ridges for a 360° grip and a proprietary distal locking mechanism, providing secure closure and stability.
• Applier Jaws: Equipped with three points of contact and a flexible hinge, allowing effective ligation of structures up to 10 mm.

Operational Mechanisms

• Trigger Grip Handle: Facilitates easy operation, while a rotational knob allows 360° shaft rotation for precise clip positioning.
• Last Clip Lockout: A built-in mechanism that indicates when the applier is empty, enhancing operational awareness.

Compatibility and Safety

• Cannula Compatibility: Suitable for use with 5 mm or 5.5 mm cannulas.
• MR Safe: No known hazards in MR environments, broadening its applicability in diverse surgical settings.

Packaging and Compliance

• Packaging: Each box contains three appliers, all sterile and intended for single use.
• Regulatory Compliance: Classified as an implantable clip applier under 21 CFR 878.4300, Class II, with clearance under 510(k) K152081.
• Material Standards: All patient-contacting materials comply with ISO 10993-1 standards, and the device is for prescription use only.

Intended Surgical Applications

The Weck® Auto Endo5® ML is versatile across a range of surgical disciplines, including general, gynecologic, thoracic, bariatric, pediatric, cardiac, colorectal, urologic, and ENT surgeries. It is contraindicated for renal artery ligation during laparoscopic living-donor nephrectomy, a precaution clearly outlined in its usage instructions.

Performance Assurance

Extensive non-clinical performance testing, including post-sterilization and environmental conditioning assessments, ensures the device meets high safety and effectiveness standards. Design validation confirms that the Weck® Auto Endo5® ML fulfills its intended operational needs without introducing new risks, making it a trusted tool in the hands of surgical professionals.