Potential Complications; Equipment Required - BD EnCor EC180 Instrucciones De Uso

• Verify secure attachment of the EnCor
to the EnCor
screw to avoid misalignment of the EnCor
Probe tip or detachment of the EnCor
• The EnCor
™
conjunction with the appropriate EnCor
• Do not use in the presence of infection.
• After use, this product may be a potential biohazard. Handle
and dispose of in accordance with acceptable medical practice
and applicable local, state, and federal laws and regulations.
Precautions
• This device should only be used by physicians trained in
percutaneous biopsy procedures.
• Carefully inspect the device prior to use to verify that device has not
been damaged. Do not use if product damage is evident.
• Sterilization of the device is not necessary under normal use conditions.

Potential Complications

Potential complications may include, but are not limited to hematoma,
hemorrhage, infection, adjacent tissue injury, pain, allergic reaction,
and tissue adherence to the EnCor
removal from the breast (as per routine biopsy procedures, it may
be necessary to cut tissue adhering to the stylet or coaxial while
removing it from the breast).
Note: Users and/or patients within the European Union, should report
any serious incident that has occurred in relation to the device to the
manufacturer and the competent authority of the Member State in
which the user and/or patient is established (https://ec.europa.eu/
growth/sectors/medical-devices/contacts). Users outside of the
European Union should report any serious incident that has occurred
in relation to the device to the manufacturer and the regulatory
authority of the country in which the user and/or patient is established.

Equipment Required

The following equipment is required for a biopsy procedure:
• Appropriate imaging modality and accessories
• Appropriate biopsy probe and system
• Stereotactic biopsy table
• EnCor Needle Guide
™
• EnCor Needle Guide Insert
™
• EnCor Fire Forward Adapter
™
• Surgical gloves and drapes
• Local anesthetic
Fire Forward Accessory mounting pins and
™
Fire Forward Accessory should only be used in
Breast Biopsy Driver
™
™
Breast Biopsy Driver.
™
Needle Guide.
™
Breast Biopsy Probe during
™
2
Breast Biopsy