ST MARKS RETRACTOR FIG-1 29,0CM

ST. MARKS RETRACTOR • FIG-1 • 29.0CM • CE-CLASS I • ISO 13485:2016

Specialized, Blunt Pelvic Retractor for Controlled and Safe Exposure in Proctological, Colorectal and Perineal Surgery

The ST. MARKS RETRACTOR Type FIG-1 (29.0 cm) is a Class I medical device manufactured according to ISO 13485:2016. This special, blunt and widely flared retractor is designed for optimal and tissue-sparing exposure of the anal canal, perineum, and deep pelvic floor. Its unique design enables broad, yet atraumatic retraction in sensitive anatomical regions.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Classic St. Marks Shape (Fig-1): Widely flared, blunt blade for maximum visibility with minimal tissue trauma
✔ Optimal length of 29.0 cm for precise work in the depth of the pelvis and perineum
✔ High-quality Surgical Stainless Steel 1.4301 – rust-proof, corrosion-resistant and tissue-friendly
✔ Fully atraumatic design: All edges and the blade tip are heavily rounded and polished
✔ Ergonomic, closed finger ring for sensitive and controlled guidance
✔ Matte finish to reduce light glare
✔ Sterilizable and reusable

Benefits of the St. Marks Retractor:

• Optimal Exposure of the Anal Canal and Perineum: The wide, flared blade gently and effectively retracts soft tissues (skin, mucosa, sphincter muscle) to create a clear, deep operative field for proctological procedures.
• Maximum Patient Safety: The blunt, highly rounded design minimizes the risk of unintended perforations or injuries to the delicate rectal and anal mucosa as well as the underlying musculature.
• Reduced Tissue Trauma: Distributes retraction pressure evenly over a larger area, thereby avoiding pressure necrosis or tears.
• Ideal for Fistula and Abscess Surgery: Particularly suitable for exposing fistula tracts during fistulotomy or for draining perianal and ischiorectal abscesses.
• Proven Standard Instrument: An indispensable instrument in colorectal surgery, proctology, and for certain gynecological or urological perineal approaches.

Technical Specifications:

• Type: St. Marks Retractor (Fig-1) / Blunt Pelvic/Proctology Retractor
• Model: FIG-1
• Overall Length: 29.0 cm
• Blade Shape: Wide, flared (fan-shaped), with heavily rounded sides and a broad, rounded tip
• 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:

• Proctological procedures (hemorrhoidectomy, fissurectomy, fistulotomy)
• Drainage and treatment of perianal and ischiorectal abscesses
• Reconstructive procedures on the sphincter apparatus (e.g., sphincter repair)
• Certain approaches in colorectal surgery (e.g., per-anal microsurgical excisions)
• Gynecological perineal procedures and episiotomy care
• Urological perineal approaches

Important Safety and Handling Information:

• FOR USE BY SURGICAL PROFESSIONALS WITH EXPERIENCE IN PROCTOLOGICAL/COLORECTAL SURGERY ONLY.
• Atraumatic Handling: The instrument is designed for gentle, even pressure. No levering or forced insertion.
• Caution with Inflamed Tissue: Particularly careful application in acutely inflamed, edematous, or friable tissue (e.g., with abscesses) to avoid tissue tears.
• Pre-Use Inspection: Before each use, inspect for damage, sharp edges, or deformations of the rounded blade surfaces.
• Thorough Cleaning: Due to the wide blade surface and application in bacterially contaminated areas, particularly thorough cleaning and disinfection after each use is essential.