Interject® Sclerotherapy Needle

Prescriptive Information

Refer to the operator's manual for complete instructions for use.

Indications

Indications for endoscopy to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

Contraindications

Contraindications for this device are those applicable to injection therapy and include, but may not be limited to, those patients allergic to sclerosing or vasoconstriction agents and patients with lesions inappropriate for injection therapy with sclerosing or vasoconstriction agents.

Warnings

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Potential Adverse Events

Potential adverse events include, but may not be limited to:

• Bleeding
• Perforation
• Pleural effusion
• Hepatic failure
• Chest pain
• Post-injection ulceration with delayed bleeding
• Esophageal stricture
• Aspiration pneumonia
• Dysphasia
• Septicemia
• Esophageal ulcers
• Other respiratory difficulties

Please be aware that potential adverse events may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.