VersaVue™ Tablet and Video Box Indications, Safety, and Warnings

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Brief Summary Document — HCP

Product

VersaVue™ Tablet and VersaVue Video Box – US IFU DOC.No. 82.5015-000001. A Ver.

VersaVue™ Tablet and VersaVue Video Box – EU IFU DOC.No. 82.5015-000002. B Ver.

Rx statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

Intended use

The VersaVue Tablet and VersaVue Video Box are plug-and-play visualization modules that are used with disposable VersaVue Cystoscopes to project images onto a monitor.

Contraindications

Visualization module 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

Warnings

Refer to VersaVue™ Tablet and VersaVue™ Video Box User Manual for all applicable information on Warnings.

Cautions

Refer to VersaVue™ Tablet and VersaVue™ Video Box User Manual for all applicable information on Cautions.

Potential adverse events

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

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VersaVue™ Tablet and Video Box