Resectr Directions for Use

DEVICE DESCRIPTION

Resectrs are non-powered, hand-held, and hand-manipulated manual surgical instruments to dissect, resect, and / or remove tissue.

Resectrs may be used through the working channel of an appropriately sized hysteroscope as an accessory instrument. Resectrs consist of a non-oscillating outer cannula, and an internal rotating-oscillating Blade. Resectr dimensions are determined by the model number

INTENDED USE / INDICATIONS FOR USE

Resectrs are single-use, non-powered, hand-held, and hand-manipulated manual surgical instruments intended to be used in various hysteroscopic surgical procedures to dissect, resect, and / or remove tissue.

CONTRAINDICATIONS

• Use of this device is contraindicated whenever hysteroscopy is contraindicated. See the operator’s manual of your hysteroscope for absolute and relative contraindications.
• Acute pelvic inflammatory disease.
• Inadequate uterine distention and / or visualization.
• Cervical / vaginal infection.
• Known pregnancy.
• Cervical malignancies and / or invasive carcinoma of the cervix.
• Recent uterine perforation.
• Patients receiving anti-coagulant therapy or who may have bleeding disorders.
• Medical contraindication or intolerance to anesthesia.
• Severe anemia on patients undergoing hysteroscopic myomectomy.
• Inability to circumnavigate a myoma due to myoma size (e.g., predominantly intramural myomas with small submucous components)