Indications, Safety, and Warnings INTACT BREAST LESION EXCISION SYSTEM

Indications

  • The Intact breast lesion excision system is indicated to provide tissue samples for diagnostic sampling of breast abnormalities
  • The Intact breast lesion excision system is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality
  • The Intact breast lesion excision system is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality
  • The Intact breast lesion excision system is intended to preserve lesion architecture in samples with a diameter of 12–30mm

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpable or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Intact breast lesion excision system may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

TRAINING

This device should only be operated by medical professional with clear knowledge of human breast anatomy and physiology, along with general stereotactic and ultrasound biopsy equipment and procedures.

GENERAL WARNING

  • No modification of this equipment is allowed.
  • Failure of RF surgical equipment could result in an unintended increase in output power.
  • Provide as much distance as possible between the Controller and other electronic equipment in the room (such as monitors) because high frequency surgical equipment may adversely
  • influence the operation of other electronic equipment.
  • In sensitive body structures, RF energy can cause neuromuscular stimulation.

PATIENT SAFETY WARNINGS

  • During the procedure, do not allow the patient to contact metal objects such as surgical table frame or instrument table and avoid skin to skin contact by using gauze if needed.
  • Use only a monitoring neutral electrode (patient return electrode). System will not function with non-monitoring electrode.
  • Ensure that the patient return electrode is properly connected and operational before initiating the procedure. Refer to manufacturer's instructions for use.
  • Create a 6–8 mm (for 10, 12mm and 15mm device) or 10-12mm (for 20mm device) wide and at least 6 mm deep incision with a cold scalpel blade to allow the entrance of the Precursor Electrode or bladed tip and to optimize vacuum performance.
  • Ensure that Precursor Electrode or the bladed tip is positioned at least 6mm below the skin surface before energizing either the Precursor Electrode or the cut/capture electrode to allow proper vacuum operation and prevent patient skin burns.
  • Be sure the vacuum is connected to the disposable biopsy device and that the vacuum unit is turned on and functioning properly prior to initiating RF energy.
  • Ensure enough time has elapsed to permit the anesthesia to permeate the tissue so as to avoid pooling of fluid, which could be exposed to the electrosurgical current.

OPERATOR SAFETY WARNINGS

  • Use caution when using the device in close proximity to metal objects.
  • Do not activate either the Precursor Electrode or the Cutting/Capture electrode if it is in contact with a metal object.
  • Do not wrap any of the electrical cords around a metal object.
  • Ensure that the Handle is clean and dry before use. This statement does not apply to the Wand since it should be not only clean and dry but sterile following removal from sterile pouch/tray.
  • Ensure that the Wand is fully seated within the Handle before activating the system.
  • Do not withdraw the Precursor Electrode or the Cutting/Capture Electrode while the electrode is activated.
  • Do not touch the Precursor Electrode or the Cutting/Capture Electrode while the electrode is activated.
  • Do not activate RF current while the Tissue Retractor is inserted in the incision.
  • Keep the safety sheath on the bladed tip until just prior to the procedure to avoid puncture wounds.