Description
Product Description
Cook Medical G22526 - NEEDLE, ACUJECT, VARIABLE, INJECTION, VIN-25, EACH
AcuJect Variable Injection Needle
Used for endoscopic injection into gastrointestinal mucosa. This device is supplied sterile and is disposable.
- Intended for single use only.
- Adjustment capability allows accurate needle length extension.
Features and Benefits
- Smooth needle advancement and retraction
- Clear outer catheter with white inner catheter allows visualization of needle advancement
- Inner and outer catheters lock together to secure the advanced needle during injection
- Adjustment capability for desired needle length extension
| Order Number | Reference Part Number | Needle gage | Needle Tip Extension (mm) | Catheter Size (Fr) | Catheter Length (cm) | Minimum Accessory Channel (mm) |
| G22526 | VIN-25 | 25 | 4 | 7 | 220 | 2.8 |
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 |
Notes
This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.
- Do not use this device for any purpose other than stated intended use
If package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook for return authorization.
- Store in a dry location, away from temperature extremes.
- Use of this device restricted to a trained healthcare professional
Contraindications
Those specific to primary endoscopic procedure to be performed in gaining access to desired injection site.
- Severe coagulopathy
Potential Complications
- Those associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.
- Those associated with mucosal injection include, but are not limited to: ulceration or necrosis of injected tissue, venous thrombosis, stricture formation.
- Others to be considered if injection is performed in esophagus include, but are not limited to: chest pain, mediastinitis, pleural effusion.
Instructions for Use
- Securely attach a pre-filled syringe to Luer lock fitting on device, then flush air from needle. Check for patency and leaks.
- With needle fully retracted into sheath, introduce device into accessory channel of endoscope.
- Advance device in short increments until it is visualized exiting endoscope.
- Endoscopically visualize desired injection site and maintain position of endoscope.
- With sheath in endoscopic view, advance and secure needle by firmly engaging Luer slip fitting into adjustment wheel. Note: If desired, needle extension may be adjusted by withdrawing needle into sheath and fine tuning needle extension using adjustment wheel. Caution: During needle adjustment or advancement, ensure sheath of device has exited endoscope completely and is within endoscopic view.
- Advance needle into mucosa, then using attached syringe perform injection.
- When injection is complete, withdraw needle from injection site and retract it into sheath by pulling back on Luer slip fitting. Repeat procedure as necessary.
- If applicable, to clear targeted area, attach a 20 cc syringe filled with sterile water to side arm fitting of device. (See fig. 6) Flush targeted area until desired effect is achieved. Repeat as necessary.
- Upon completion of procedure, retract needle into sheath, then remove device from endoscope.