VersaVue™ Single-Use Flexible Cystoscope

The VersaVue Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue Tablet OR VersaVue Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.

The Cystoscope is intended to provide visualization via displaying unit.

The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

Cystoscope must not be used if the procedure may endanger the patient according to the opinion of a qualified physician.

• Febrile patients with urinary tract infections (UTIs) or severe coagulopathy
• Patients with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
• Patients with known unpassable urethral stricture

• The distal tip of the Cystoscope may get warm due to heating from the light emission part. Avoid long periods of contact between the distal tip and the mucosal membrane as long, sustained contact with the mucosal membrane may cause mucosal injury.
• Using energized electrosurgical equipment in conjunction with the Cystoscope may disturb the image.
• Patient leakage currents may be too high, when using energized endoscopic accessories. Only energized endoscopic accessories classified as “type CF” or “type BF” applied parts shall be used with the Cystoscope to minimize the total patient leakage current.
• Cystoscope is a single-use device. Any use beyond 4 hours or frequently plug in and unplug Cystoscope may result in blurry images.

Refer to VersaVue Single-Use Flexible Cystoscope User Manual for all applicable information on Cautions.

• Bleeding
• Reaction to topical anesthesia
• Pain or discomfort
• Hematuria
• Dysuria-pain and discomfort on voiding
• Increase voiding frequency
• Urethral narrowing due to scar tissue formation
• Urinary tract infections
• Mucosal injury
• Perforation of bladder