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Brief Summary Document - HCP
Product
Urolok™ II Adaptor - IFU 51938384-01
Rx Statement
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. This device is restricted to use by or under the supervision of physicians trained in endoscopic urological biopsy procedures.
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/Indications for Use
The UroLok II Adaptor is intended to prevent irrigant backflow and to secure slippery, coated urological devices.
Contraindications
None known.
Warnings
None known.
Precautions
- Improper connections between the UroLok II Adaptor and working channel of the urological endoscope may result in leaks and user exposure to biohazardous material.
- When using the side port to drain the bladder, insufficient tightening of the side port stopcock while attached to a drainage bag may result in leakage and user exposure to biohazardous material.
- Ensure the stopcock is fully opened while using the side port to drain the bladder. Failure to open the stopcock fully may result in inadequate urine drainage.
Refer to Instructions for Use for all applicable information on Precautions.
Potential adverse events
The potential complications that may result from the use of this device include:
- Allergic Reaction
- Infection/ Sepsis
- Inflammation
- Discomfort
- Pain
- Urinary Retention
Adverse events may require additional medical or surgical intervention, or result in a prolonged procedure.