DIEFFENBACH Straight Vascular Clamp (R33003-01)

Overview

The DIEFFENBACH Straight Vascular Clamp (Model R33003-01) is a precision-engineered surgical instrument designed for temporary occlusion of blood vessels during microsurgical and open surgical procedures. Manufactured by RWD (Shenzhen), this clamp operates on a ratchet-based mechanical locking principle, delivering consistent, adjustable clamping force without slippage or tissue deformation under physiological load. Its straight configuration enables optimal access in confined anatomical fields—particularly in neurovascular, cardiovascular, and transplant surgery—where linear alignment between handle actuation and jaw orientation is critical for procedural control and ergonomics.

Key Features

• Stainless steel construction (AISI 304/316-grade equivalent) with electropolished surface finish to ensure corrosion resistance, biocompatibility, and compliance with ISO 7153-1 for surgical instruments.
• Fixed-length jaw geometry: 17 mm jaw length × 3.7 mm jaw width × 58 mm total instrument length—optimized for precise vessel engagement while minimizing adjacent tissue compression.
• Ratchet locking mechanism with three distinct engagement positions, enabling graduated occlusion pressure suitable for varying vessel wall thicknesses (e.g., carotid artery vs. cerebral perforator).
• Ergonomic finger-ring handles with matte-textured grip surface to reduce hand fatigue and enhance tactile feedback during prolonged use.
• Autoclavable up to 134 °C (273 °F) for 18 minutes per EN 285, supporting repeated sterilization cycles without degradation of mechanical integrity or surface finish.

Sample Compatibility & Compliance

This vascular clamp is validated for use with human and large-animal (porcine, canine, non-human primate) vasculature in both acute and chronic experimental models. It meets essential requirements of ISO 13485:2016 for medical device quality management systems and conforms to the general safety and performance requirements outlined in EU MDR 2017/745 Annex I. While not intended for permanent implantation, its material composition and surface characteristics are compatible with standard intraoperative anticoagulation protocols (e.g., heparinized saline irrigation). The design excludes sharp edges or crevices that could harbor biofilm, facilitating effective cleaning per AAMI ST79 and ANSI/AAMI ST98 standards.

Software & Data Management

As a manually operated, non-electronic surgical instrument, the R33003-01 does not incorporate embedded electronics, sensors, or software interfaces. Its usage documentation—including sterilization logs, maintenance records, and traceability data—is managed externally via institutional surgical instrument tracking systems compliant with FDA 21 CFR Part 11 (for electronic records) and ISO 15189 (for laboratory medicine workflows). RWD provides batch-specific material certification (CoC) and sterilization validation support documentation upon request, enabling integration into GLP/GMP-aligned preclinical study reporting frameworks.

Applications

• Temporary occlusion of medium-caliber arteries and veins (1–4 mm diameter) during aneurysm clipping, bypass grafting, and tumor resection.
• Vessel isolation in rodent and rabbit models for ischemia-reperfusion studies, where reproducible, time-controlled flow arrest is required.
• Microvascular anastomosis training—used in simulation labs to develop fine motor control and pressure modulation skills prior to live tissue practice.
• Supporting intraoperative angiography by enabling selective vessel clamping for contrast agent bolus timing and flow assessment.
• Adjunctive use in endovascular hybrid operating rooms, where external mechanical clamping complements intraluminal device deployment.

FAQ

Is this clamp MRI-compatible?
Yes—the stainless steel alloy used in the R33003-01 exhibits negligible magnetic susceptibility and has been tested for safe use in static magnetic fields up to 3 Tesla, per ASTM F2503 guidelines.
What is the recommended maximum autoclave cycle count before retirement?
Based on accelerated aging tests per ISO 17664, RWD recommends retiring the instrument after 1,000 sterilization cycles or when visible wear (e.g., ratchet tooth deformation, jaw misalignment >0.1 mm) is observed during routine inspection.
Does RWD provide instrument traceability for regulatory submissions?
Yes—each unit carries a laser-etched alphanumeric identifier linked to manufacturing batch, material lot, and final inspection report, supporting UDI compliance under FDA and EU MDR requirements.
Can this clamp be used in sterile-packaged single-use configurations?
No—it is designed and validated exclusively for reusable, multi-cycle application; RWD does not offer or validate single-use packaging for this model.
Is technical support available for surgical protocol integration?
Yes—RWD’s Application Support Team provides peer-reviewed procedural guidance documents and collaborates with institutional biomedical engineering departments to align clamp use with SOPs for ISO 15189 or CAP-accredited laboratories.