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Brief Summary Document - HCP
Product
VersaGrasp Single-Use Grasping Forceps - IFU number AP30301B
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a skilled and licensed practitioner.
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
This instrument has been designed to be used with an endoscope to retrieve foreign bodies or resected tissue from the urinary system transurethrally.
Contraindications
- Sepsis
- Untreated urinary tract infection
- Anticoagulation or uncorrected bleeding disorders
Warnings
Refer to Instructions for Use for all applicable information on Warnings.
Precautions
There are no known precautions associated with the use of this device.
Adverse events
- Perforation
- Pain/discomfort
- Infection
- Tissue damage
- Hematuria
- Hemorrhage
- Laceration
- Edema
- Inflammation
- Avulsion
The VersaGrasp Single-Use Grasping Forceps is manufactured by Anrei Medical (HZ) Co., Ltd. and distributed by Boston Scientific Corporation