The device is used to sample targeted sub-mucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.
The 19Ga. and 22Ga. BNX™ aspiration needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.
If package is opened or damaged when received, do not use. Visually inspect the device for damage, kinks, bends, or breaks. If an abnormality is detected which could interfere with appropriate device use, do not use the device. Please notify your Medtronic sales representative or contact Covidien directly.
Store the device in a dry location with ambient conditions.
Contraindictions are those specific to primary endoscopic procedure to be performed in gaining access to desired site, including coagulopathy.
Potential complications associated with gastrointestinal endoscopy include, but are not limited to, perforation, hemorrhage, aspiration, fever, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection, allergic reaction to medication, damage to blood vessels, nerve damage, tumor seeding of the needle tract and acute pancreatitis.
*Prior to Covidien’s acquisition of Beacon Endoscopic, this product was known as the BNX™ delivery system.
When removing needle from package, ensure that the needle sheath is locked in place on the needle and the sheath covers the end of the needle. If the needle sheath is not locked into place on the needle, user injury may result.
Ensure that the stylet is fully inserted when advancing the needle into the biopsy site.
Ensure that the needle hub is securely locked in the handle of the device prior to using the device. Failure to ensure that needle hub is securely locked in the handle of the device prior to use may result in damage to the endoscope or user injury.
Find more information, including other available configurations, for Beacon™ FNA needle.
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