Potential Complications; Equipment Required - BD EnCor Adaptateur vertical GE Mode D'emploi

Precautions
• The 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.
• Do not use if the product packaging is compromised.
• 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™ Breast
Biopsy Probe during 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:
• Appropriate imaging modality and accessories
• Appropriate biopsy probe and system
• EnCor™ Fire Forward Accessory
• GE™ Senographe DS
• Surgical gloves and drapes
• Local anesthetic
• Other equipment as necessary
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