Gold Probe™ Electrohemostasis Catheter

Prescriptive Information

Indications

The Gold Probe, Gold Probe Direct and Gold Probe 350cm Electrohemostasis Catheters are indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon. The indications include: peptic ulcers, angiomata, Mallory-Weiss tears, watermelon stomach, arteriovenous malformations (AVMs), Barrett's esophagus, dieulafoy lesions, angiodysplasia, bleeding polyp stalks, and esophageal tumors.

Contraindications

Contraindications known for these devices are those specific to bipolar electrocautery treatment. These contraindications include, but are not limited to non-focal bleeding sites, esophageal/gastric varices. diffuse lesions, and use of these devices with monopolar electrical generators.

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 a patient.

After use, dispose of product and packagining in accordance with hospital, administrative and/or local government policies.

Potential Adverse Effects

Potential complications may include, but are not limited to: perforation, bleeding, aspiration pneumonia, and septicemia/infection.

Please be aware that potential adverse effects 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

A thorough understanding of the technical principles, clinical application, and risks associated with bipolar electrohemostasis and injection therapy is necessary before using this product.

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.