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Indications, Safety, and WarningsThe Multifire Endo Hernia™ single-use loading unit (SULU), for use with the Multifire Endo Hernia™ 0, Endo Universal™ 65, or Multifire VersaTack™ single-use staplers has application in endoscopic and general surgery procedures for fixation of knitted mesh, in the repair of hernial defects. and in other endoscopic and open surgical procedures for approximation of tissue(s).WarningsThe stapler should not be reloaded more than four times during a single procedure. If the instrument is reloaded more than four times, staples may not form properly. Improperly formed staples may compromise staple security which may result in leakage or disruption of the staple row.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 stapler, always inspect the stapling site carefully for hemostasis. Minor bleeding may be controlled by electrocautery or 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 Multifire Endo Hernia™ 0, Endo Universal™ 65, or Multifire VersaTack™ stapler is contraindicated.Do not use the Multifire Endo Hernia™ 0, Endo Universal™ 65, or Multifire VersaTack™ 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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