MATHIEU RETRACTOR FIG-1

MATHIEU RETRACTOR • FIG-1 • 20.0CM • CE-CLASS I • ISO 13485:2016

Wide, Flatly Curved Pelvic Spatula for Initial Retraction of Bladder and Peritoneum in Gynecological and Urological Surgery

The MATHIEU RETRACTOR Type FIG-1 (20.0 cm) is a Class I medical device manufactured according to ISO 13485:2016. This broadly curved retractor with its shallow, sweeping curvature is specifically designed for the gentle, areal retraction of the urinary bladder, peritoneum, and superficial pelvic tissue. It serves as the first instrument to create access to the true pelvis.

Product Highlights:

✔ Manufactured in accordance with ISO 13485:2016
✔ CE Marked – Class I (Regulation (EU) 2017/745 – MDR)
✔ Mathieu shape FIG-1: Wide, flat curvature for large-area and superficial retraction
✔ Optimal length of 20.0 cm for good reach with excellent control
✔ High-quality Surgical Stainless Steel 1.4301 – rust-proof, corrosion-resistant and tissue-friendly
✔ Very wide, fully rounded and blunt blade tip for maximum atraumatic contact
✔ Ergonomic, closed finger ring for powerful and precise guidance
✔ Matte finish to reduce light glare
✔ Sterilizable and reusable

Benefits of the Mathieu Retractor FIG-1:

• Ideal Initial Bladder Retraction: The wide, flat curvature allows for secure and gentle displacement of the urinary bladder from the uterus and adnexa to create access to the operative site.
• Protection of Hollow Organs: The large-area, blunt design distributes pressure evenly and minimizes the risk of iatrogenic injury to the bladder or bowel wall.
• Optimal Exposure of the Anterior Uterine Wall: After retraction of the bladder, it provides a clear view of the corpus uteri, uterine arteries, and anterior parametria.
• Versatile Application: Also excellent for retracting the peritoneum or bowel loops in the true pelvis.
• First Instrument in the Mathieu Set: Used for the superficial retraction layer before the deeper FIG-2 is employed.

Technical Specifications:

• Type: Mathieu Retractor (FIG-1) / Flatly Curved Pelvic Spatula
• Model: FIG-1 (shallower curvature)
• Overall Length: 20.0 cm
• Blade Shape: Very wide, with a shallow, sweeping curvature 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:

• Initial retraction during abdominal hysterectomy
• Exposure of the anterior uterine wall and uterine arteries
• Bladder retraction during myomectomy or adnexal surgery
• Displacement of bowel loops in the true pelvis
• Cystectomy in urology

Important Safety and Handling Information:

• FOR USE BY GYNECOLOGICAL OR UROLOGICAL SURGICAL PROFESSIONALS ONLY.
• Identification of Bladder Margin: Before application, the inferior border of the bladder must be identified to avoid accidental entry into the bladder lumen.
• Atraumatic Application: The instrument is designed for gentle, even pressure. No levering or forced insertion.
• Caution with Adhesions: Particular care is required in patients with previous pelvic surgery (e.g., status post C-section).
• Visual Inspection: Before each use, inspect for deformations of the wide blade surface.