A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

A Retrospective Multicenter Investigation of the Use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures

A retrospective multicenter investigation of the use of the da Vinci® Surgical System in Non-Tumor Based TORS Procedures. The study objectives are to evaluate the safety and effectiveness of the da Vinci Surgical System in subjects undergoing Benign Non-tumor procedures.

Primary Effectiveness Endpoint:

• Ability to complete procedure without a need for conversion to a non-robotic approach

Safety Endpoint:

Assessment of adverse events through post-operative follow-up including but not limited to:

• Bleeding

▪ Mortality

Additional endpoints evaluated may include:

• Procedure times
• Length of hospital stay
• Volume of tissue resected
• Use of tissue sealants

Inclusion Criteria:

• The specific surgical procedure involved a lingual tonsillectomy, tongue base resection, or a partial glossectomy procedure.
• Subject was ≥18 years of age at the time of procedure

Exclusion Criteria:

• Subject underwent a benign non-tumor TORS procedure that did not involve either a lingual tonsillectomy, tongue base resection or partial glossectomy.
• Subject underwent a TORS procedure for oropharyngeal cancer