HEGAR-OLSON Needle Holder (with Scissors Function)

Overview

The HEGAR-OLSON Needle Holder (with Scissors Function), model F31037-14, is a dual-function surgical instrument engineered for precision suture handling and controlled tissue trimming in sterile clinical and preclinical laboratory environments. Designed according to the classical HEGAR-OLSON geometry—featuring opposing serrated jaws with longitudinal grooves and integrated distal blade edges—it combines secure needle grasping with on-the-spot cutting capability without requiring instrument exchange. This configuration adheres to established biomechanical principles for optimal torque transmission during needle penetration and controlled leverage during suture tensioning. The device operates manually, requiring no power source or consumables, and is intended for repeated sterilization via autoclaving (134 °C, 2–3 bar saturated steam) in accordance with ISO 17664 and AAMI ST79 guidelines.

Key Features

• Dual-function design: Integrated needle-holding jaws and distal micro-scissors enable seamless transition between suture placement and thread trimming.
• Ergonomic handle geometry: Full-size 350 mm (13.8 in) length provides optimal mechanical advantage and tactile feedback for fine motor control under magnification.
• High-grade stainless steel construction: Made from ISO 7153-1 compliant austenitic stainless steel (equivalent to ASTM F899 UNS S44004 or DIN 1.4122), ensuring corrosion resistance, hardness (>52 HRC), and dimensional stability after repeated sterilization cycles.
• Optimized jaw surface: Cross-hatched serrations (12–14 lines per mm) enhance grip retention on stainless steel, alloy, and polymer-based suture needles without slippage or deformation.
• Autoclavable and reusable: Validated for ≥100 cycles of steam sterilization per manufacturer’s durability testing; compatible with standard instrument tracking and reprocessing workflows.

Sample Compatibility & Compliance

The F31037-14 is compatible with all standard suture needle types used in general surgery, ophthalmology, plastic surgery, and rodent survival surgery—including reverse-cutting, taper, and spatula-point needles ranging from 1/2 to 5/8 circle curvature and diameters from 0.3 mm to 0.8 mm. It meets ISO 7153-1:2016 (Surgical instruments — Metallic materials) and conforms to GB/T 25440.1–2010 (Chinese national standard for surgical instruments). While not classified as an active medical device under EU MDR 2017/745 or FDA 21 CFR Part 878, it is supplied with full traceability documentation (material certification, heat lot traceability, and sterilization validation summary) required for GLP-compliant preclinical studies and ISO 13485-certified manufacturing facilities.

Software & Data Management

This is a manual, non-electronic surgical instrument; therefore, it does not incorporate embedded electronics, firmware, or software interfaces. No data acquisition, connectivity, or digital record-keeping functionality is present. Instrument usage, maintenance history, and sterilization logs must be managed externally through facility-specific instrument tracking systems (e.g., RFID-tagged trays or barcode-linked reprocessing databases) in compliance with Joint Commission EC.02.05.01 and AORN Recommended Practices for Instrument Management.

Applications

• Acute and chronic wound closure in small animal models (mice, rats, rabbits) under IACUC-approved protocols.
• Suturing of delicate tissues including cornea, dura mater, and vascular grafts where minimal needle deflection and consistent bite depth are critical.
• Training modules in surgical skills laboratories for residents and veterinary students practicing knot-tying, tissue approximation, and layered closure techniques.
• Microsurgical procedures requiring simultaneous needle manipulation and suture tail excision to minimize intraoperative instrument exchanges and maintain field sterility.
• Manufacturing QA/QC verification of suture needle geometry and coating integrity using controlled clamping force assessment.

FAQ

Is this instrument certified for human clinical use?
Yes—model F31037-14 complies with ISO 7153-1 and carries CE marking under Class I (non-sterile, reusable) per MDD 93/42/EEC. It is cleared for human surgical use in jurisdictions recognizing CE conformity; local regulatory approval (e.g., NMPA registration in China, FDA 510(k) in the U.S.) should be verified prior to deployment.
What is the recommended sterilization protocol?
Autoclaving at 134 °C for 5 minutes (pre-vacuum cycle) is validated. Do not use chemical immersion or low-temperature plasma methods, as they may compromise surface passivation or blade edge integrity.
Can this holder accommodate curved needles larger than 5/8 circle?
No—the jaw opening and arc geometry are optimized for needles up to 5/8 circle; oversized or ultra-large-radius needles may exhibit reduced rotational stability and increased risk of slippage during penetration.
Does RWD provide instrument maintenance or sharpening services?
RWD offers optional lifetime sharpening and calibration services through authorized service centers; users must submit instruments with completed service request forms and sterilization documentation to ensure traceability.
Is the F31037-14 available with custom engravings or color-coded handles?
Yes—OEM/ODM customization is available for research institutions and hospitals requiring asset tagging, departmental identification, or ergonomic handle coatings (e.g., textured polymer overmold); minimum order quantities apply.