GYNECARE VERSAPOINT™ Bipolar Electrosurgery System

The GYNECARE VERSAPOINT System is used hysteroscopically in normal saline solution distention medium for the correction of the following pathologies: myomas, polyps, intrauterine adhesions and uterine septa. It may also be used to treat abnormal uterine bleeding by endometrial ablation. The system allows for diagnosis and treatment of these conditions in a single intervention.

VERSAPOINT™ Sistema Bipolar

Product Specifications

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00466 00466 Ball tip electrode 

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00467 00467 Twizzle tip electrode 

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00468 00468 Spring tip electrode 

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00480 00480  

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00481 00481  

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01735 01735 Resectoscope hysteroscopic bridge/visual obturator 

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01931 01931 Resectoscope working element - passive 

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01934 01934 Resectoscope obturator - standard 

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01936 01936  

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01938 01938 Hysteroscope 4.0mm 12 degree high magnification lens 

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01939 01939 Resectoscope rotating outer sheath 27Fr 

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01950 01950 Bipolar electrode, resectoscopic - vaporizing tip CO degree) 

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01985 01985 Bipolar electrode, resectoscopic - angled loop tip 

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04995 04995  

Resources

GYNECARE VERSAPOINT™ Bipolar Electrosurgery System
GYNECARE VERSAPOINT System and Technique Video for Surgeons
0:09:05
GYNECARE VERSAPOINT System In-Service Video for Nurses
0:10:25

Supporting Documentation

Product Support

GYNECARE VERSAPOINT Brochure

GYNECARE VERSAPOINT System - Helpful Hints

References

GYNECARE VERSAPOINTTM Bipolar Electrosurgery System

Essential Product Information

The GYNECARE VERSAPOINTTM Bipolar Electrosurgery System is used to diagnose and treat various benign uterine pathologies, including submucosal fibroids and polyps, as well as treat abnormal uterine bleeding by endometrial ablation.

Indications for Use
The GYNECARE VERSAPOINT™ Hysteroscopic System is an electrosurgical system used in conjunction with continuous-flow hysteroscopes for correction of the following pathologies:

  • Myomas
  • Polyps
  • Intrauterine adhesions
  • Uterine septa

The GYNECARE VERSAPOINTTM Resectoscope is used to permit direct viewing and access to the uterine cavity for the purpose of performing hysteroscopic surgical procedures. The GYNECARE VERSAPOINTTM Electrodes are indicated for use in tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa and benign conditions requiring endometrial ablation. 
The indications for use include: 

  • Removal of submucous fibroids

  • Removal of polyps
  • Transection of intrauterine adhesions
  • Transection of intrauterine septa

  • Endometrial ablation

Contraindications
The GYNECARE VERSAPOINTTM Bipolar Electrosurgery System is contraindicated where hysteroscopic bipolar electrosurgical procedures in normal saline solution are contraindicated.
The GYNECARE VERSAPOINTTM Bipolar Electrosurgery System is contraindicated in any non-hysteroscopic surgical procedure and in procedures where normal saline solution is not used as an irrigation and distention medium.
The use of this device is contraindicated in patients with the following conditions: acute cervicitis, pregnancy, cervical or uterine malignancy, acute pelvic inflammatory disease, and unaddressed adnexal pathology.

The GYNECARE VERSAPOINTTM Bipolar Electrosurgery System is contraindicated for use in tubal sterilization procedures.

Use with extreme caution and very close fluid monitoring in the face of severe cardiopulmonary disease.

Potential Adverse Effects
Contact of the heated GYNECARE VERSAPOINTTM Electrode tip with tissues not intended for electrosurgical treatment may result in tissue injury.
If excessive heating or physical forces cause damage to the GYNECARE VERSAPOINTTM Electrode tip, foreign body fragments may result, requiring extended surgery for removal.
Reported adverse effects include uterine perforation, hemorrhage, fluid overload and gas embolization.

WARNINGS 
For hysteroscopic procedures, be alert to these potential hazards:
•    Perforation, hemorrhage, fluid overload and gas embolization.
•    Potential complications of continuous flow hysteroscopy using saline as a distention medium include:
         o    Hypothermia
         o    Uterine perforation resulting in possible injury to bowel, bladder, major blood vessels, and ureter.
         o    Pulmonary edema
         o    Cerebral edema 
•    The accessory tip may remain hot enough to cause burns after the electrosurgical current is deactivated.
•    Inadvertent activation or movement of the GYNECARE VERSAPOINTTM Electrode outside the field of vision may result in injury to the patient.
•    Localized burns to the patient or physician may results from electrosurgical current carried through other instruments and conductive objects.
•    Do not activate the generator when the active electrode is not in contact with tissue or excessive heating of the irrigation medium may result and patient injury could occur.
•    If excessive heating or physical forces cause damage to the GYNECARE VERSAPOINT TM Electrode tip, foreign body fragments may result, possibly requiring extended surgery for removal.
•    Refer to the GYNECARE VERSAPOINT TM Electrode package insert for warnings for explosion hazard, electric shock hazard, and fire hazard.

Warnings applicable to Air/Gas Emboli Hazards
•    Gas bubbles are a normal by-product of electrosurgical procedures performed in liquids. When bubbles occur in the uterus, care should be taken to manage the removal of air/gas bubbles to minimize the inherent risk of emboli. Bubbles produced during tissue vaporization may interrupt surgery by temporarily interfering with vision and may also result in electrode over heating causing damage to the electrode tip. A continuous flow fluid management system is recommended to prevent accumulation of bubbles and continuously remove bubbles from the operative field.
•    Surgeons should consider the anticipated length of surgery and size of leiomyomata when selecting patients for procedures. 
•    Surgeons should consider the selection of electrodes prior to initiating procedures. The electrode should be matched to the size and type of pathology. 
•    Operating room personnel must be trained to purge air from fluid lines prior to surgery, avoid entry of air into fluid lines and turn off pumps during bag changes, and to provide constant, careful attention to fluid deficits. Avoid situations where the fluid bag runs dry.
•    Basic equipment should be available to fulfill the requirements for monitoring of fluid deficit, assessment and control of intrauterine pressure and anesthesia monitoring. Intrauterine pressure should be maintained as low as possible so as to allow adequate distension and minimize forces potentially driving air and gas into circulation.
•    Surgical team must have access to appropriate resuscitative capabilities.
•    Patients should be kept flat or in reverse Trendelenberg position.
•    If room air or gas embolism is suspected, surgeon should consider interrupting surgery, deflating the uterus and removing sources of fluid and gas until the diagnosis and a management plan are clarified.
•    Surgeon should avoid entry of air into uterus by:
         o    Carefully purging air from fluid in-flow lines and hysteroscopic devices prior to use.
         o    Following cervical dilatation, care should be taken to minimize the exposure of the open cervix to room air.
         o    Keeping the cervical os occluded during surgery as much as possible once it is dilated.
         o    Using active fluid out-flow to effectively flush the uterus of bubbles and debris. 
         o    Using a Y-connector on the fluid in-flow line in order to reduce air entrainment during bag changes.
         o    Initially selecting the appropriate electrode, to avoid further cervical dilatation and insertion of larger instruments after initiation of the procedure.
         o    Minimizing the frequency of removal and reinsertion of hysteroscopic devices.
•    Considerations for anesthesia:
         o    Nitrous oxide anesthesia may enlarge the size of air bubbles, and thus should be avoided when possible in operative hysteroscopy.
         o    Patients at high risk for room air and gas embolism should be managed using controlled ventilation.
         o    For high risk patients undergoing operative hysteroscopy one should consider intraoperative monitoring, such as end-tidal CO2 monitoring if under general anesthesia, and pre-cordial Doppler monitoring to detect room air and gas emboli early.

Precautions
Refer to the GYNECARE VERSAPOINTTM Bipolar Electrosurgery System package insert and User Manual indications and instructions to ensure all safety precautions are met.
For complete product information, consult product instructions for use.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.