C-22-05

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<h2>Indications, Safety, and Warnings</h2> <h3>Intended use</h3> <p>The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.</p> <h3>Notes</h3> <ul> <li>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.</li> <li>Store the device in a dry location with ambient conditions.</li> <li>Use of this device is restricted to trained healthcare professionals.</li> <li>When using a previously used SharkCore™ FNB needle (from the same procedure) or replacement needle of similar or different size, please go to step 19 of the instructions for use section.</li> </ul> <h3>Warnings</h3> <ul> <li>Do not use this device for any purpose other than the stated intended use.</li> <li>This product is supplied sterile and is intended for single use only. Do not re-sterilize or re-use. It has not been designed to be re-used/re-sterilized. Reprocessing may lead to changes in material characteristics which may impact the strength of the device and compromise device performance. Re-use of single use devices can also cause cross contamination leading to patient infection. These risks may potentially affect patient safety. After use, dispose of product and packaging per institutional guidelines for biohazardous medical waste.</li> <li>The SharkCore™ FNB needle should only be used in conjunction with the Beacon™ EUS delivery system.</li> </ul> <h3>Contraindications</h3> <ul> <li>Contraindications are those specific to primary endoscopic procedure to be performed in gaining access to desired site, including coagulopathy.</li> <li>Potential complications</li> <li>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, and acute pancreatitis.</li> <li>Potential complications associated with EU needle biopsy include, but are not limited to, bleeding, pain, death, peritonitis, infection/bacteremia, tumor seeding of the needle tract, and needle fracture requiring intervention for removal.</li> </ul> <h3>Precautions</h3> <ul> <li>Refer to package label for minimum endoscope channel size required to use this device.</li> <li>Needle must be retracted into sheath and thumbscrew on the locking safety ring must be securely locked to hold needle in place prior to introduction, advancement, or withdrawal of the device or introduction, advancement, or withdrawal of the needle during needle exchange. Failure to retract the needle may result in damage to the endoscope.</li> <li>*Prior to Covidien’s acquisition of Beacon Endoscopic, this product was known as the BNX™ delivery system.</li> <li>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.</li> <li>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.</li> </ul>

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