GI Supply: Spot

Spot is the first and only non India ink based FDA approved product for marking or “tattooing” the GI tract. Each syringe contains 5cc of a sterile, biocompatible, non-pyrogenic suspension containing highly purified carbon particles. The particles remain in the submucosal injection site creating a permanent mark that remains visible on the mucosal and serosal surfaces of the colon.

India ink preparations contain shellac, phenol, and ammonia that, even in dilute solutions, would preferably be avoided. Spot's special formulation does not contain India ink and clinical studies show Spot to be a safe, effective, and convenient method for marking GI lesions.

Specifications - The GI Supply: Spot

SPOT is a specially formulated, biocompatible agent designed for endoscopically marking or “tagging” lesions in the GI tract. SPOT is a suspension containing highly purified, very fine carbon particles. The particles remain in the submucosal injection site creating a permanent mark. Each steam sterilized, non-pyrogenic syringe contains 5cc of the marker. The composition of SPOT is as follows:

• Water for Injection
• Glycerol
• Polysorbate 80
• Benzyl Alcohol
• Simethicone
• High Purity Carbon Black

Indication for Use:
SPOT is indicated for endoscopically marking lesions (such as colon cancer and polyps) in the GI tract when the endoscopist anticipates the lesion will require surgical removal within 30 days.

Contraindications:
SPOT is contraindicated in patients with a known hypersensitivity to any of the ingredients in the product.

Warnings and Precautions:
Some settling of the carbon pigment is normal. The syringe should be shaken vigorously prior to loading the injection needle.

SPOT is a sterile single-use only product. Sterile unless damaged. Leakage of product may be evidence of damage. Do not use. Discard any unused product after the syringe has been opened. Although the material is non-toxic, the marker may stain clothing or porous materials.

When using a sclerotherapy needle in the colon, the needle should be inserted into the colon wall at an angle so that the beveled tip of the needle is entirely beneath the mucosa. If the needle is inserted perpendicular to the mucosa, there is a risk of penetrating the serosa and injecting the marker directly into the peritoneal cavity.

Side Effects:
During the clinical study, no adverse effects or patient discomfort were reported with SPOT. However, any inadvertent injection of marker into the intraperitoneal space should be monitored closely for adverse reactions.

Storage and Shelf Life:
Store the product at room temperature. The product has a shelf life of two years. The expiration date and the lot number are printed on the syringe label. Store the syringes in the canister provided with the syringe tips pointed upward. Do not store with the syringe tips pointing down. Storing the syringes with tips down may allow a portion of the pigment to settle into the narrow syringe outlet and prevent the pigment from being re-suspended.

For more information, visit the GI Supply: Spot Website