OMS-XB2

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>The PDB™ dissection balloon , is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space.</p> <h3>Contraindications</h3> <p>Use of the PDB™ dissection balloon , is contraindicated in situations where previous surgeries in the extraperitoneum may have created adhesions in the area of extraperitoneal organs. Use is also contraindicated where laparoscopic surgery is contraindicated.</p> <h3>Warnings and precautions</h3> <ul> <li>Endoscopic procedures should be performed by persons having adequate training and familiarity with endoscopic techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of any endoscopic procedure. Complications such as hematoma, transient neuropathy, inadvertent cystotomy, urinary retention, peritoneal tearing, infection, and orchitis may be encountered during extraperitoneal procedures.</li> <li>Balloon products must be treated with care. Damage to balloons by instruments used during insertion and in the course of a procedure may cause product failure.</li> <li>Overinflation of the balloon can result in balloon rupture. Do not pump the PDB™ dissection balloon more than 30–40 pumps. </li> <li>Where adhesions, small pelvic size or previous surgeries exist, inflate slowly and limit the amount of inflation to that appropriate to anatomical considerations.</li> <li>Forceful insertion of the distention balloon or tunneling below the pubic bone is to be avoided as this may cause injury to the organs and structures in the extraperitoneal space.</li> <li>Use of a mineral-oil based lubricant in conjunction with the PDB™ dissection balloon is not recommended.</li> <li>This device is provided sterile and is intended for use in a singular procedure only. Discard after use. Do not resterilize.</li> </ul>

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