5
Adverse Reactions
•
Potential complications are limited to the region surrounding the biopsy site and
include hematoma, hemorrhage, infection, pain and tissue adherence to the
biopsy probe while removing it from the breast. As per routine biopsy procedures,
it may be necessary to cut tissue adhering to the biopsy probe while removing it
from the breast.
•
Patients receiving anticoagulant therapy or who may have bleeding disorders
may be at increased risk.
•
Use of products manufactured or distributed by companies not authorized by
Devicor Medical Products, Inc. may not be compatible with the Mammotome elite
System and may lead to unanticipated results, EMC issues and possible injury to
the user or patient.
•
The Probe is packaged and sterilized for single use only. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and/or lead to
device failure or contamination that in turn may result in patient injury, illness or
death.
Illustration 1: Device Assembly Illustration and Nomenclature
