KOCHER RETRACTOR 8 PRONGS SHARP 22,0CM

KOCHER RETRACTOR • 8 SHARP PRONGS • 22.0 CM • CE CLASS I • ISO 13485:2016

The Specialized Instrument for Broad-Area Retraction of Massive Soft Tissue Masses Under Extreme Conditions

The KOCHER Retractor with 8 sharp prongs, 22.0 cm is a Class I medical device according to ISO 13485:2016 and represents the absolute specialist class among manual retractors. This instrument is developed for highly specific and demanding surgical scenarios where extremely broad-based, firmly anchored, and controlled retraction of large-volume, maximally tense soft tissue is required.

Product Highlights:

✔ Certified according to ISO 13485:2016
✔ CE marking Class I (Regulation (EU) 2017/745)
✔ KOCHER design with reinforced, anatomical hammer handle
✔ 8 sharp prongs for unparalleled width coverage and holding security
✔ High-grade stainless steel 1.4435/316L – corrosion-resistant, biocompatible, and high-strength
✔ Biocompatibility tested according to ISO 10993
✔ Finely ground, sharp prong tips for secure tissue engagement
✔ Total length 22.0 cm for deep and extensive surgical access
✔ Autoclavable and suitable for repeated reprocessing when protocols are followed

Advantages of the KOCHER Retractor (8 sharp prongs):

• Unparalleled Width Coverage: Eight prongs provide maximum contact area and enable the secure retraction of extensive, large-volume tissue masses (e.g., entire muscle groups) that cannot be adequately held with narrower hooks.
• Optimal Pressure Distribution: The high number of prongs distributes retraction pressure evenly across a very large tissue area, minimizing locally damaging peak pressures.
• Excellent Control: Despite its size, the ergonomically shaped, robust hammer handle allows for precise guidance and measured force application.
• For Specialized Mass Retraction: Designed for situations where conventional 4 or 6-prong hooks reach their limits in terms of surface area coverage.
• High-Performance Manufacturing: Crafted using sophisticated forging and finishing techniques to withstand exceptional mechanical stress.

Technical Specifications:

• Model: KOCHER Retractor with Hammer Handle (Special Version)
• Type: 8 sharp prongs
• Total Length: 22.0 cm
• Handle: Reinforced Hammer Handle
• Prong Shape: Eight parallel, sharp prongs
• Material: High-strength surgical stainless steel 1.4435 / 316L
• Surface: High-gloss polished, passivated
• Processing: Autoclavable up to 135°C, suitable for repeated reprocessing (according to steam sterilization cycle)
• Special Feature: Specialized instrument for maximum holding width during retraction of large-volume soft tissue masses
• Risk Class: I according to Regulation (EU) 2017/745 (MDR)

Fields of Application (Highly Specialized Indications):

• Major orthopedic surgery and orthopedic tumor surgery for extensive soft tissue resections or mobilizations
• Complex reconstructive procedures in Plastic Surgery involving large flaps and significant tissue tension
• Specific procedures in Trauma Surgery for avulsive injuries with large soft tissue defects
• Selected neurosurgical approaches requiring retraction of powerful muscle sections

CRITICAL APPLICATION NOTES AND SAFETY WARNINGS:
• FOR USE BY HIGHLY QUALIFIED AND EXPERIENCED SURGICAL PERSONNEL ONLY.
• SPECIALIZED INSTRUMENT WITH ELEVATED RISK PROFILE. Use requires profound knowledge of tissue biomechanics and advanced retraction techniques.
• Mandatory Pre-Use Inspection: Before each use, a comprehensive inspection for structural integrity (no cracks, bends), sharpness of all prongs, and perfect condition of all components must be performed.
• Strictest Indication: Only for the retraction of massive, dense, and large-volume soft tissue under strict benefit-risk assessment. Contraindicated for any normal, thin, or vulnerable tissue, as well as near critical neurovascular structures.
• Reprocessing Note: Due to the many narrow spaces between prongs, careful manual pre-cleaning before automated reprocessing is essential to avoid residue buildup. Regular inspection by instrument service is required.
• Discard Policy: In case of any defect (dulling, micro-bending, scratches with crack potential), the instrument must be taken out of service immediately and submitted to the certified manufacturer's service for assessment and maintenance. No user repair.