LigaSure™ robotic-assisted surgery (RAS) Maryland jaw vessel sealer-divider

Surgeries using this instrument carry some residual risk, even when used by trained physicians. The potential adverse events associated with the use of this device include, but are not limited to; airway obstruction, allergic reaction, arrhythmia, bleeding, burns (including thermal and bowel), carcinogen exposure, cardiac arrest, electric shock, foreign body in patient, infection, nerve damage, perforation (including vessel and organ), thromboembolism, and tissue trauma. Use of this equipment without specific procedure training may result in serious unintended patient injury.

The Hugo™ RAS system was evaluated for its effectiveness and safety of specific procedures as a surgical tool for controlling robotic instruments, but not for clinical outcomes related to cancer or other diseases. The potential adverse events associated with the use of robotically assisted surgical devices include, but are not limited to: arrhythmia, bleeding, blunt trauma, bowel perforation, burns (varying degrees, bowel, thermal), crushing injury, delay of treatment (prolonged procedure), electric shock, foreign body in patient, infection, inflammation, tissue damage/trauma, toxicity, or vessel perforation. Please refer to the Hugo™ RAS system user guide and the Hugo™ RAS system indications document for complete indications, contraindictions and risk information.