Cook Medical G32701 - EXTRACTOR, STONE, NCOMPASS, NITINOL, TIPLESS, EACH
NCompass Nitinol Stone Extractor
The NCompass Nitinol Stone Extractor, featuring multiwire geometry, is designed to improve stone-free rates. The unique multiwire geometry provides a traditional 3 or 4 wire basket design at full deployment, while partial closure reconfigures the basket to provide the exceptionally tight weave of a 12 or 16 wire basket.
The duality of the NCompass extractor allows both routine capture and extraction of intact stones and features an improved design to capture multiple small fragments following intracorporeal lithotripsy. When used in conjunction with the latest minimally invasive stone-treatment technologies, the NCompass Nitinol Stone Extractor will assist your efforts in rendering the patient stone free.
In 1998, Cook Medical introduced the world to NCircle nitinol tipless basket technology-a revolutionary advance in the area of stone manipulation. The development of the NCompass Nitinol Stone Extractor demonstrates our continued commitment to being the world leader in nitinol stone extractor technologies. The NCompass Nitinol Stone Extractor is used for stone manipulation and removal in the urinary tract. The extractors are supplied sterile in peel-open packages.
| Order Number | Reference Part Number | Fr | Length (cm) | Basket Diameter (cm) | Basket Configuration | Tip Configuration |
| G32701 | NCT4-024115 | 2.4 | 115 | 1.0 | 4 wire, 16 wire | Tipless |
Features
- Intricate Multiwire Geometry: Dual basket design: a standard 3 or 4 wire design at complete deployment, an intricate 12 or 16 wire design during closure. At full deployment, distal portion provides a netting effect to help prevent migration of stones.
- Tipless Design: The tipless basket design follows in the tradition of the NCircle basket. Atraumatic design reduces trauma to surrounding tissue.
- Nitinol Alloy: Resilient memory characteristics retain preformed shape when deployed. Kink resistance creates a durable basket to withstand multiple deployments. Flexibility allows expedient capture and release of stones.
- Flexible Sheath: Permits continuous, full deflection of the ureteroscope during stone manipulation.
- 1.7 Fr Sheath: Allows improved irrigation flow through endoscopic working channel.
Intended Use
The NCompass Stone Extractors are intended for stone manipulation and removal in the urinary tract.
Precautions
- These products are intended for use by physicians trained and experienced in urological procedures. Standard urological techniques should be employed.
- This device is conductive. Avoid contact with any electrified instrument.
- Enclose the device in the sheath before removing from the tray/holder.
- Do not use excessive force to manipulate this device. Damage to the device may occur.
Procedure
- At complete deployment the NCompass stone extractor features standard openings at the proximal portion of the basket to allow stone entry.
- The multiwire area at the distal portion of the basket captures the stones as the basket is withdrawn through the ureter, preventing stone migration.
- As the NCompass stone extractor is gradually closed, the intricate multiwire geometry completely encompasses the stones for secure capture and extraction.
Device Characteristics
| 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 |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Instructions for Use
- Remove the stone extractor from its outer package and move the thumb lever on the handle to the "Close" position to close the basket.
- Place the instrument insertion adapter (if included) securely into the endoscopic cap on the scope.
- With the insertion adapter in place, carefully insert the instrument into the scope.
- Under direct visualization, locate the stone and advance the extractor to a location just proximal to the stone. Slide the thumb lever on the handle to the "Open" position to deploy the basket near the stone and maneuver the device until the stone is within the basket.
- Once correctly positioned, draw the basket down around the stone and slide the thumb lever into the Close position.
- Maintaining position of the stone within the basket, retract the scope and basket.
How Supplied
Supplied sterile by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use 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 the package, inspect the product to ensure no damage has occurred.
