ROUX RETRACTOR • FIG-2 • 15.0CM • CE-CLASS I • ISO 13485:2016

Medium-Depth Liver Retractor for Stable Exposure of the Liver Hilum and Central Upper Abdominal Organs

The ROUX RETRACTOR Type FIG-2 (15.0 cm) is a Class I medical device manufactured according to ISO 13485:2016. As the middle variant of the Roux set, this retractor offers a balanced curvature designed for retraction at medium depth and exposure of central upper abdominal structures such as the liver hilum, portal vein, and gastric antrum.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Medium Roux shape (FIG-2): Balanced curvature for universal retraction at medium depth
✔ Optimal length of 15.0 cm for good leverage and control in the mid-upper abdomen
✔ High-quality Surgical Stainless Steel 1.4301 – rust-proof, corrosion-resistant and durable
✔ Wide, rounded spatula tip with medium curvature for secure hold and atraumatic contact
✔ Ergonomic, closed finger ring for precise guidance
✔ Matte finish to reduce light glare
✔ Sterilizable and reusable

Benefits of the Roux Retractor FIG-2:

• Optimal Exposure of the Liver Hilum: The medium curvature allows precise and gentle lifting of the liver parenchyma to optimally expose the structures of the liver hilum (hepatic artery, portal vein, bile duct).
• Versatile Use in the Central Upper Abdomen: Ideal for retracting the gastric antrum, pancreatic head, or transverse colon during pancreatic or gastric procedures.
• Safe Retraction of Mid-Depth Layers: Provides more depth effect than the FIG-1, while offering better control and lower risk than the very deep FIG-3.
• Protection of the Biliary Tract: Enables safe retraction of the liver during procedures on the extrahepatic bile ducts, such as common bile duct revisions or bilio-digestive anastomoses.
• Important Link in the Roux Set: Allows the gradual transition from superficial to deep retraction during a complex procedure.

Technical Specifications:

• Type: Roux Retractor (FIG-2) / Medium-Depth Liver-Upper Abdominal Spatula
• Curvature: Medium (between FIG-1 and FIG-3)
• Overall Length: 15.0 cm
• Blade Shape: Wide, moderately curved, with 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:

• Exploration and dissection of the liver hilum
• Pancreatic head resection (Whipple procedure)
• Gastrectomy and gastric antrum resection
• Reconstructive procedures on the bile ducts
• Adhesiolysis and revision procedures in the central upper abdomen
• Spleen-preserving distal pancreatectomy

Important Safety and Handling Information:

• FOR USE BY VISCERAL SURGICAL PROFESSIONALS ONLY.
• Caution with Portal Hypertension: Particular care is required in patients with portal hypertension and variceally transformed vessels in the hilum.
• Identification of Hilar Structures: Before retraction, the vascular and ductal structures in the hilum should be identified to avoid injury.
• Not for Extreme Deep Retraction: For exposure of the inferior vena cava or hepatic veins, the FIG-3 is more suitable.
• Thorough Cleaning: Thorough cleaning is required after procedures involving the biliary system.