Medtronic Signia SDR Product Surveillance Registry | NCT05095935

Label	Description	Intervention Names
Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Other: N/A observational registry
Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Other: N/A observational registry
Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.	Other: N/A observational registry

Name	Type	Description	Arm Group Labels	Other Names
N/A observational registry	Other	N/A observational registry	Abdominal Adult Abdominal Pediatric Thoracic Adult

Measure	Description	Time Frame
Incidence of Intraoperative Hemostatic Intervention	Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins. Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins. Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).	During Procedure

Measure	Description	Time Frame
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications		30 days
Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale	The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon).

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center		Los Angeles	California	90048	United States
Children's Hospital Colorado

ID	Title	Description
FG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
FG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 25, 2025	Dec 2, 2025

ID	Title	Description
BG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
BG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
BG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000123 BG001163 BG00295 BG003381

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Intraoperative Hemostatic Intervention

Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins.
Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins.
Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).

Analysis was conducted on the number of firings of the Signia SDR device. Study participants could have 1 or more firings.

Posted

Count of Units

Firings

During Procedure

Firings

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts
Participants	OG000123 OG001163 OG00295
Firings	OG000

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0012 OG0020

Secondary

Incidence of Repeat Hospital Admission for Primary Procedure-related Complications

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts
Participants	OG000

Secondary

Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale

The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon).

Posted

Count of Participants

Participants

During Procedure

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts

Secondary

Intraoperative Assessments: Incidence of Staple Line Bleeding

Number of firings that had an incidence of staple line bleeding of >50cc

Posted

Count of Units

Firings

During Procedure

Firings

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts
Participants	OG000

Secondary

Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure

Additional interoperative interventions to treat staple line failure (applying additional stapler reloads, applying compression greater than what is considered typical, over-sewing with suture, placing clips, use of energy, use of seatbelt, other)

Posted

Count of Participants

Participants

During Procedure

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts
Participants

Secondary

Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure

Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.

Units	Counts
Participants

Secondary

Device Deficiencies

incidence of subjects reporting device deficiencies affecting the intended performance of the device up to and including 30 days following the use of device (i.e. Signia™ Small Diameter Reloads) in surgery

Posted

Count of Participants

Participants

30-days

ID	Title	Description
OG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients. N/A observational registry: N/A observational registry
OG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients. N/A observational registry: N/A observational registry
OG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients. N/A observational registry: N/A observational registry

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood Loss Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Non-systematic Assessment	EG00024 events24 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG00010 events10 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Atrial Flutter	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Bradycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Extrasystoles	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Melaena	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Drug Intolerance	General disorders and administration site conditions	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Burkholderia Cepacia Complex Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Empyema	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Enterobacter Pneumonia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Infectious Pleural Effusion	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Acinetobacter	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG00010 events10 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Escherichia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Fungal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Klebsiella	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Pseudomonal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0004 events4 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0008 events7 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumonia Streptococcal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Post Procedural Pneumonia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pseudomonal Bacteraemia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Stenotrophomonas Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Streptococcal Bacteraemia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Systemic Candida	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Abdominal Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Post Procedural Fever	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0005 events5 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Procedural Pneumothorax	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Vascular Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Vasoplegia Syndrome	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Device Leakage	Product issues	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG00013 events12 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0003 events3 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0006 events6 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0003 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0005 events5 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Subcutaneous Emphysema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Arterial Haemorrhage	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Shock	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Venous Haemorrhage	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0021 events1 affected95 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0022 events2 affected95 at risk
Adverse Drug Reaction	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Pyrexia	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Allergy To Surgical Sutures	Immune system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Bacteraemia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Incision Site Discharge	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Post Procedural Constipation	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0010 events0 affected163 at risk EG0021 events1 affected95 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Device Leakage	Product Issues	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk
Haematuria	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected123 at risk EG0011 events1 affected163 at risk EG0020 events0 affected95 at risk
Arterial Haemorrhage	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected123 at risk EG0010 events0 affected163 at risk EG0020 events0 affected95 at risk

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Thoracic Adult	Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	123	43	123	6	123
EG001	Abdominal Adult	Use of Signia SDR for the transection of renal arteries and veins in adult patients.	163	7	163	6	163
EG002	Abdominal Pediatric	Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.	95	4	95	8	95