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.
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
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
The study population will include pediatric participants aged less than (\<) 18 years of age and adult participants of at least 18 years of age in whom at least one vessel is planned to be transected by the HARMONIC 700 Shears as per the instructions for use (IFU).
Cohort
Prospective
HARMONIC 700 Shears
DeviceThere is no intervention, beyond necessary clinical care, in this study. HARMONIC 700 Shears for vessel transection were used according to instructions for use.
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis
Number of vessel transection with achievement of Grade 3 or lower hemostasis for each vessel transection will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (for example \[e.g.\], pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.
Number of Participants with Device-Related Adverse Events (AEs)
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
Number of Vessel Transections With an Achievement of Grade 3 or Lower Hemostasis for Each Vessel Transection of Diameter Greater Than (>) 5 to 7 Millimeter (mm)
Number of vessel transections with achievement of Grade 3 or lower hemostasis for each vessel transection of diameter \> 5 to 7 mm will be reported as per the grading scale as follows- Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, basic energy devices (monopolar and/or bipolar) and/or touch-ups with HARMONIC 700 Shears; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures.
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