A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures

A Prospective, Single-Arm Multi-Center Study of the HARMONIC™ 700, 5 mm Diameter Shears With Advanced Hemostasis in Pediatric Surgical Procedures (General) and Adult Surgical Procedures (General, Gynecological, Urological, and Thoracic)

The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical procedures.

Inclusion Criteria:

Pediatric participants

• Non-emergent procedure (general) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
• Less than 18 years of age at the time of procedure
• Participant's parent/legal guardian must give permission to participate in the study and provide written informed consent for the participant Adult participants
• Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU
• Elective procedure (general, gynecological, urological, or thoracic) where at least one vessel is planned to be transected by the HARMONIC 700 Shears per the IFU

Exclusion Criteria:

Preoperative

• Physical or psychological condition which would impair study participation
• Participants of childbearing potential who are pregnant
• Enrollment in a concurrent interventional clinical study that could impact the study endpoints Intraoperative
• HARMONIC 700 Shears were not attempted to be used for at least one single vessel transection during the surgical procedure