CASTROVIEJO Micro Spring-Loaded Scissors S11004-09
| Brand | RWD |
|---|---|
| Origin | Shenzhen, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | S11004-09 |
| Price | USD 67 (approx.) |
Overview
The CASTROVIEJO Micro Spring-Loaded Scissors S11004-09 is a precision surgical instrument engineered for fine dissection and delicate tissue manipulation in ophthalmic, neurosurgical, plastic, and microvascular procedures. Designed in accordance with the classical CASTROVIEJO geometry—originally developed for corneal and scleral incisions—the S11004-09 features a 9 cm overall length, angled blades with a blunt-tip configuration on both jaws, and an integrated stainless steel spring mechanism that ensures consistent, fatigue-resistant actuation. Its blade geometry supports controlled, low-slip cutting in confined anatomical spaces, minimizing lateral tissue displacement and reducing mechanical trauma during high-magnification surgery. Constructed from medical-grade austenitic stainless steel (AISI 420 or equivalent), the scissors undergo passivation, electropolishing, and rigorous dimensional inspection to meet ISO 7153-1:2016 standards for surgical instruments.
Key Features
- Blade configuration: Angled (curved) profile with dual blunt tips—optimized for safe navigation around sensitive ocular structures, neural bundles, and vascular pedicles.
- Spring-loaded mechanism: Precision-ground torsion spring housed within the handle assembly enables rapid, repeatable opening without manual finger repositioning—critical during prolonged microsurgical sessions.
- Material integrity: Forged stainless steel body with Rockwell hardness ≥52 HRC; fully autoclavable (up to 134 °C, 21 min, saturated steam per ISO 17664).
- Ergonomic handle design: Smooth, non-ribbed contour with balanced weight distribution (approx. 28 g) reduces hand fatigue and enhances tactile feedback under microscope visualization.
- Surface finish: Electropolished to Ra ≤ 0.4 µm, minimizing protein adhesion and facilitating effective cleaning validation per AAMI ST79:2023 guidelines.
Sample Compatibility & Compliance
These microscissors are intended for single-user, reusable application in sterile environments. They are compatible with standard ultrasonic cleaning systems (40–60 kHz), alkaline enzymatic detergents, and low-temperature sterilization cycles (e.g., hydrogen peroxide plasma). The device complies with ISO 13485:2016 quality management system requirements and conforms to the essential safety and performance requirements outlined in Regulation (EU) 2017/745 (MDR) for Class I reusable surgical instruments. While not intended for implantation, the S11004-09 supports traceability through laser-engraved model number and manufacturer identification mark (RWD®) on the upper shank—facilitating internal inventory control and GLP-aligned instrument log maintenance.
Software & Data Management
As a manually operated mechanical instrument, the S11004-09 does not incorporate embedded electronics, firmware, or digital interfaces. Accordingly, no software, drivers, or data export functionality is associated with this device. Instrument usage records—including sterilization cycle logs, sharpening history, and functional verification checks—must be maintained manually or via institutional CMMS (Computerized Maintenance Management Systems) in alignment with ISO 15223-1:2021 labeling conventions and FDA Guidance for Industry: Reprocessing Medical Devices in Health Care Settings (2022). Reconditioning and resharpening services are available through authorized RWD-certified service centers; all post-service calibration documentation adheres to ISO 17025:2017 competency criteria.
Applications
- Ophthalmology: Corneal graft trimming, conjunctival incision refinement, iris sphincterotomy, and intraocular lens haptic adjustment.
- Neurosurgery: Dural opening under high magnification, arachnoid dissection, and cranial nerve mobilization in skull base approaches.
- Plastic & Reconstructive Surgery: Fascial sling tail trimming, dermal flap thinning, and microanastomotic vessel adventitia removal.
- Experimental Research: Rodent cerebral cortex dissection, zebrafish yolk sac vasculature isolation, and avian embryo membrane excision in developmental biology models.
- ENT & Laryngology: Vocal fold microflap elevation, stapedectomy tendon dissection, and tympanic membrane graft shaping.
FAQ
What is the recommended sterilization method for the S11004-09?
Steam sterilization at 134 °C for 21 minutes is validated and preferred. Ethylene oxide and hydrogen peroxide plasma are acceptable alternatives when steam exposure may compromise adjacent instrumentation.
Can these scissors be sharpened in-house?
Yes—but only by personnel trained in microinstrument sharpening using diamond-lapped ceramic stones and verified with optical profilometry. Unqualified resharpening risks blade asymmetry and increased cutting force.
Is the spring mechanism replaceable?
The torsion spring is integral to the forged handle assembly and is not field-replaceable. Functional degradation necessitates return to RWD’s certified service center for evaluation and full refurbishment.
Does this model comply with USP or requirements?
While the instrument itself is not subject to USP compounding standards, its surface finish and cleanability support compliance when used in ISO Class 5 environments for sterile preparation workflows.
What is the expected service life under routine clinical use?
With proper cleaning, inspection, and biannual functional verification, typical service life exceeds 5 years—consistent with ISO 15223-1 durability benchmarks for Class I reusable devices.
