BABY-ALLIS 4×5 Tooth Tissue Forceps

Overview

The BABY-ALLIS 4×5 Tooth Tissue Forceps is a precision-engineered surgical instrument designed for secure, atraumatic manipulation and stabilization of soft tissue during open and minimally invasive procedures. Based on the classic Allis clamp geometry, this miniature variant features four longitudinal rows of five finely spaced, non-slip teeth per row—engineered to maximize grip while minimizing tissue compression and slippage. The 3 mm jaw width and 13 cm overall length provide optimal control in confined anatomical fields, particularly in gynecological, urological, plastic, and general surgical applications where delicate tissue handling is critical. Constructed from high-grade austenitic stainless steel (AISI 304 or equivalent), the forceps undergo rigorous passivation and electropolishing to ensure corrosion resistance, biocompatibility, and compatibility with standard sterilization protocols including autoclaving (134°C, 2 bar, 18 min), ethylene oxide (EtO), and low-temperature hydrogen peroxide plasma.

Key Features

• 4×5 interlocking tooth configuration: Uniformly distributed micro-teeth (approx. 0.15 mm tip radius) deliver high-friction engagement without deep tissue penetration or crushing.
• Angled, ergonomic handle design with textured finger rings: Enhances tactile feedback and reduces hand fatigue during prolonged use.
• Precision-machined ratchet mechanism: Provides six incremental locking positions for adjustable clamping pressure—critical for maintaining hemostasis or retraction without compromising tissue viability.
• Smooth, burr-free surface finish: Meets ISO 7153-1:2016 requirements for surgical instruments; surface roughness Ra ≤ 0.4 µm post-electropolishing.
• Autoclavable up to 2000 cycles: Validated per ISO 17664-1 for reprocessing instructions and material stability under repeated thermal stress.

Sample Compatibility & Compliance

The BABY-ALLIS 4×5 Tooth Tissue Forceps is intended for single-user, multi-cycle reuse in human surgical settings. It is compatible with all standard biological tissues—including fascia, uterine myometrium, vaginal mucosa, adipose tissue, and bowel serosa—without inducing measurable mechanical trauma under recommended usage parameters. The device complies with ISO 13485:2016 (Medical Devices – Quality Management Systems), ISO 10993-1:2018 (Biological evaluation of medical devices), and EN 29187-2:1993 (Surgical instruments – Requirements and test methods for reusable instruments). Sterilization validation documentation, including bioburden limits and sterility assurance level (SAL) of 10⁻⁶, is available upon request for institutional procurement compliance.

Software & Data Management

As a manually operated, non-electronic surgical instrument, the BABY-ALLIS 4×5 Tooth Tissue Forceps does not incorporate embedded software, sensors, or data transmission capabilities. Its performance metrics—including grip force profile, jaw alignment tolerance, and ratchet retention load—are validated during batch release testing per ISO 80601-2-77:2021 Annex BB and documented in the Device Master Record (DMR). Traceability is maintained via laser-etched alphanumeric identifiers (model + serial batch code) on the shank, supporting GLP-compliant inventory tracking and FDA UDI (Unique Device Identification) registration under GUDID submission guidelines.

Applications

• Retraction and stabilization of anterior vaginal wall during colporrhaphy or hysterectomy.
• Controlled grasping of bladder peritoneum in pelvic floor reconstruction.
• Secure handling of rectus sheath during component separation techniques.
• Temporary fixation of skin flaps in reconstructive dermatology and maxillofacial surgery.
• Manipulation of intestinal mesentery during laparoscopic-assisted colectomy (used via 5 mm port).

FAQ

Is this instrument certified for sterile processing in healthcare facilities?

Yes—validated for steam sterilization per AAMI ST79:2023 and compatible with automated washer-disinfectors meeting ISO 15883-1 standards.
What is the maximum recommended torque for ratchet closure?

Ratchet engagement is calibrated to require ≤ 1.2 N·m at the handle; over-torquing may compromise tooth alignment and jaw parallelism.
Can these forceps be used in MRI environments?

No—stainless steel construction renders them ferromagnetic; they are contraindicated in MRI suites per ASTM F2503-22 guidelines.
Does RWD provide IFU translations for international distribution?

Yes—multilingual Instructions for Use (English, Spanish, French, German, Japanese) are supplied with each consignment and comply with EU MDR Annex I §23.2.
Are replacement parts or repair services available?

RWD offers full refurbishment services including jaw realignment, ratchet recalibration, and re-passivation—subject to pre-approval via DMR review.