173054

Indications, Safety, and WarningsThe Endo Universal™ 65 universal hernia stapler has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).WarningsWhen articulating the instrument, confirm that the shaft Roticulator™ collar has been locked into place. Failure to lock the nose may result in improperly formed staples which may compromise the integrity of the staple line.The stapler should not be reloaded more than four times during a single endoscopic procedure. If the instrument is reloaded more than four times, staples may not form properly. Improperly formed staples may compromise the integrity of the staple closure which may result in leakage or disruption.When endoscopic instruments and accessories from different manufacturers are employed together in a single procedure, verify compatibility and ensure that electrical isolation or grounding is not compromised.PrecautionsAfter application of the Endo Universal™ 65 universal hernia stapler, always inspect the stapled site carefully for hemostasis. Minor bleeding may be controlled by electrocautery or manual sutures.ContraindicationsStaples can be applied directly over underlying bone, vessels or viscera, but during application there must be a distance of no less than 4.8 mm (when using a 4.8 mm staple) or 4 mm (when using a 4 mm staple) from the surface of the tissue to the underlying bone, vessels or viscera. If this distance cannot be obtained by lifting the tissue prior to application, use of the stapler is contraindicated.Do not use the stapler where hemostasis cannot be visually verified after application.Please refer to instructions for use for complete contraindication and risk information.

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