ROUX RETRACTOR FIG-1 14,0CM

ROUX RETRACTOR • FIG-1 • 14.0CM • CE-CLASS I • ISO 13485:2016

Flat Liver and Upper Abdominal Spatula for Gentle, Superficial Retraction in Visceral and Biliary Surgery

The ROUX RETRACTOR Type FIG-1 (14.0 cm) is a Class I medical device manufactured according to ISO 13485:2016. As the flattest and widest spatula of the Roux set, this retractor is specifically designed for the initial, broad, and very gentle retraction of liver lobes (especially the left liver lobe), gastric fundus, or colon. Its flat curvature minimizes the risk of parenchymal injury.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Flattest Roux shape (FIG-1): Low curvature for maximum contact area and minimal pressure
✔ Compact overall length of 14.0 cm for excellent control during superficial retraction
✔ High-quality Surgical Stainless Steel 1.4301 – rust-proof, corrosion-resistant and tissue-friendly
✔ Extremely wide, fully rounded and blunt spatula tip for atraumatic contact
✔ Ergonomic, closed finger ring for sensitive guidance
✔ Matte finish to reduce light glare
✔ Sterilizable and reusable

Benefits of the Roux Retractor FIG-1:

• Ideal Initial Liver Retraction: Perfectly suited to gently and securely hold the left liver lobe or lateral segments of the right lobe cranially, providing access to the liver hilum, gallbladder, or stomach.
• Maximum Pressure Distribution: The flat, wide shape distributes retraction force over a large area, reducing the risk of parenchymal tears or crush injuries, especially in fatty or cirrhotic livers.
• Protection of Hollow Organs: Also ideal for gently retracting the colon (transverse colon) or greater omentum from the surgical field.
• Optimal Overview in Upper Abdominal Approaches: Creates a broad and superficial visual field for procedures such as cholecystectomy, fundoplication, or proximal gastric surgery.
• Safe Basic Instrument: The flat angle makes it particularly controllable and reduces the risk of unintentionally penetrating into deeper layers.

Technical Specifications:

• Type: Roux Retractor (FIG-1) / Flat Liver-Upper Abdominal Spatula
• Curvature: Flat (lowest curvature of the Roux series)
• Overall Length: 14.0 cm
• Blade Shape: Very wide, flatly curved (plateau-shaped), with fully rounded edges
• Material: Surgical Stainless Steel 1.4301 (AISI 304)
• Surface Finish: Satin (matte)
• Handle: Closed, oval ring
• Sterilization: Autoclavable up to 138°C (Steam Sterilization)
• Packaging: Individually packed in sterilizable peel pouch
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Areas of Application:

• Laparoscopic and open cholecystectomy
• Fundoplication (Nissen, Toupet)
• Procedures on the gastric fundus and cardia
• Initial retraction steps in liver resections
• Retraction of the transverse colon or greater omentum
• General surgical approaches in the right and central upper abdomen

Important Safety and Handling Information:

• FOR USE BY SURGICAL PROFESSIONALS ONLY.
• Atraumatic Handling: The instrument is designed for gentle, areal pressure. No levering or using the edge.
• Caution with Portal Hypertension: In pronounced portal hypertension with a congested liver, the liver tissue is particularly fragile and prone to rupture.
• Not Suitable for Deep Retraction: Due to its flat curvature, this hook is not intended for reaching deep structures such as the vena cava or pancreatic head. For this, the more curved FIG-2 or FIG-3 hooks should be used.
• Visual Inspection: Before each use, inspect the flatness and integrity of the wide spatula surface.