FOMON Double-Pronged Retractor (Blunt-Tipped, 10 mm Blade Width)
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Country of Origin | China |
| Model | R21014-1 |
| Pricing | Upon Request |
Overview
The FOMON Double-Pronged Retractor (Model R21014-1) is a precision-engineered surgical retractor designed for controlled, atraumatic tissue displacement during open and minimally invasive procedures. Manufactured by RWD (Shenzhen), a certified ISO 13485-compliant medical device producer, this instrument employs a dual-prong configuration with blunt-tipped, parallel blades to distribute mechanical load evenly across soft tissue surfaces—minimizing localized pressure necrosis and reducing the risk of iatrogenic trauma. Its 10 mm blade width and 14.5 cm overall length provide optimal leverage and depth access for medium-depth cavities, including abdominal, thoracic, and orthopedic exposure sites. The retractor operates on passive mechanical retraction principles, requiring no power source or consumables, and is intended for repeated sterilization via autoclaving (134 °C, 3 bar, 18 min) in accordance with EN 285 and ISO 17664 standards.
Key Features
- Blunt-tipped, double-prong design ensures uniform tissue contact and eliminates sharp edge penetration risks
- 10 mm wide, polished stainless steel blades with mirror-finish surface (Ra ≤ 0.4 µm) to reduce tissue adherence and facilitate cleaning
- 14.5 cm total length optimized for ergonomic handling and deep-field visualization without excessive handle extension
- Weight-optimized construction: net weight 31 g supports fatigue-reduced manipulation during prolonged procedures
- Fully reusable architecture compliant with AAMI ST79:2017 guidelines for steam sterilization cycles
- Laser-etched model number (R21014-1) and manufacturer identifier (RWD) on shank for traceability and inventory control
Sample Compatibility & Compliance
This retractor is compatible with human and large-animal surgical applications where gentle, sustained retraction of muscle, fascia, or peritoneal layers is required. It is not indicated for neurosurgical microdissection or vascular clamping. The device conforms to ISO 7153-1:2016 (surgical instruments — metallic materials — Part 1: Stainless steels) and meets biocompatibility requirements per ISO 10993-1:2018 (cytotoxicity, sensitization, and irritation testing). RWD’s manufacturing facility maintains full regulatory documentation for CE marking under MDR 2017/745 Annex II, and the product is registered with China NMPA (National Medical Products Administration) as a Class I sterile reusable surgical instrument.
Software & Data Management
As a manually operated, non-electronic surgical instrument, the FOMON Double-Pronged Retractor does not incorporate embedded electronics, firmware, or data output capabilities. However, it integrates seamlessly into digitally enabled operating room workflows through standardized instrument tracking protocols. Hospitals utilizing RFID-enabled instrument management systems (e.g., Getinge T-DOC or Steris TrakCare) can assign unique identifiers to each unit for cycle logging, maintenance scheduling, and GLP-aligned audit trails. All sterilization records—including autoclave batch numbers, temperature/time profiles, and biological indicator results—must be retained per ISO 13688:2013 and FDA 21 CFR Part 820.170 for traceability and quality system compliance.
Applications
- Abdominal surgery: Retraction of rectus abdominis sheath and transversalis fascia during laparotomy
- Orthopedic exposure: Stabilized retraction of vastus lateralis during lateral femoral approach
- Thoracic procedures: Gentle separation of intercostal muscles in posterolateral thoracotomy
- Veterinary large-animal surgery: Subcutaneous and muscular layer retraction in equine and bovine coeliotomy
- Medical education: Standardized tool for teaching safe retractor technique and force modulation in simulation labs
FAQ
Is the R21014-1 retractor suitable for single-use applications?
No. This is a reusable instrument designed for ≥100 autoclave cycles when maintained per RWD’s IFU and ISO 17664 cleaning validation protocols.
What sterilization methods are validated for this retractor?
Steam sterilization (gravity displacement and pre-vacuum cycles) is fully validated. Ethylene oxide (EtO) and hydrogen peroxide plasma are not recommended due to potential material degradation and residue retention.
Does the device include a locking mechanism?
No. It is a manual, non-ratcheting retractor requiring continuous operator control—consistent with AORN Guideline 2023 recommendations for low-risk, short-duration exposures.
Can the prongs be adjusted or angled intraoperatively?
No. The prongs are fixed at 0° divergence to maintain dimensional stability and reproducible tissue interface geometry across clinical use cases.
Where can I access the full Instructions for Use (IFU) and sterilization validation report?
Authorized distributors and healthcare procurement portals provide downloadable IFU documents (EN/ES/FR/DE versions) and summary sterilization validation dossiers upon institutional registration.
