A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs) up to and including 30 days, including intra- and post-operative leaks. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria:

Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in:

• Resulted in a life-threatening illness or injury, or
• Resulted in a permanent impairment of a body structure or a body function, or
• In-patient or prolonged hospitalization, or
• Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

The primary endpoint is the number of subjects reporting serious adverse device effects (SADEs), including intra- and post-operative leaks up to and including 30 (+14) days post-procedure. A Serious Adverse Device Effect (SADE) is an adverse event related to the use of an investigational medical device, that is deemed serious in nature. To be deemed serious, and adverse event must meet one or more of the following criteria:

Led to a death, b. Led to a serious deterioration in the health of the subject, that either resulted in:

• Resulted in a life-threatening illness or injury, or
• Resulted in a permanent impairment of a body structure or a body function, or
• In-patient or prolonged hospitalization, or
• Medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function, or c. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

The secondary endpoint is device deficiencies/malfunctions affecting the intended performance of the device. All recorded device deficiencies/malfunctions were captured and assessed by the Investigator. A Device Deficiency is defined as inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

Note: Device deficiencies include malfunctions, use errors, and inadequate labeling.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. B formation is defined as consistent formation of the staple-line fired by the Signia Stapling System handle.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of staple-line bleeding (measured as > 50 cc) refers to occurrences of bleeding at the staple-line only, and not in the study procedure as a whole.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of intra-operative leakage as measured by air leak test performed by the surgeon, or standard of care, as applicable.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative leakage as evidenced confirmed by imaging, subject presentation or decline in status, or need for re-operation/re-intervention.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Prolonged air leaks are considered >7 days in duration.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Number of post-operative infection was assessed by the Investigator according to the standard of care and site policy, ex. Positive wound culture.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. Examples of additional interventions to treat staple-line failure include: glue, manual over sew, Medtronic buttress as additional reinforcement, or intraoperative revision/recreation of the anastomosis.

The secondary endpoint is device deficiency/malfunctions affecting the intended performance of the device including: intra- and post-operative staple line assessments. The number of repeat hospital admissions for primary procedure-related complications was assessed.