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Cook Medical G02601 - NEEDLE, BREAST, KOPANS MOD, DKBL-20-7.0-A, EACH
Kopans Breast Lesion Localization Needle
The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation.
- Bevel-cut needle tip guides the needle to the optimum position for placing the localization hook wire.
- Reference burnish mark, when visible just outside the needle hub on the spring-hook wire, provides visual assurance that the hook wire is within the needle tip during needle manipulation.
- Needle is marked in 1 cm increments for depth guidance during a procedure.
- The reinforced tip of the spring-hook wire serves as a visual and palpable landmark for the surgeon to gauge distance to the lesion during dissection and reduces the risk of severing the hook wire.
Used for preoperative marking of nonpalpable breast lesions.
|Order Number||Reference Part Number||MR Status||Needle gage||Length cm|
The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
|Device Packaged as Sterile||Yes|
|Requires Sterilization Prior to Use||No|
|What MRI safety information does the labeling contain?||Labeling does not contain MRI Safety Information|
|Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):||No|
|Device labeled as "Not made with natural rubber latex":||No|
|Prescription Use (Rx):||Yes|
|Over the Counter (OTC):||No|
|Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):||No|
Under no circumstances should a hookwire engaged in tissue be pulled out without surgical intervention.
- This product is made of ferrous material and has not been tested for safety in the MR enviroment.
- The product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for localization of breast lesions should be employed.
- Following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement.
- Final hookwire position should be confirmed by appropriate imaging modality.
- The hookwire should be used as a guide for the surgeon, not a retractor.
Potential Adverse Events
- Internal bleeding and/or bleeding at the puncture site
- Puncture or injury to target organ or to a nearby organ that is traversed by the needle.
- Damage of tissue adjacent to the needle
Instructions for Use
NOTE: The burnish mark on the hookwire should be seen just outside the needle hub to ensure that the hookwire is within the needle tip during needle manipulation.
- Introduce the needle into the lesion.
- Check the position of the needle.
- Advance and release the hookwire.
- Remove the needle.
- Bend the hookwire protruding from the breast and tape flat to the skin.
- Verify final hookwire position.
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.