Study: NCT04203667

Adverse event: Mucosal Laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Onset time: Procedure Severity: Severe Relationship to EndoRotor: Unlikely Relationship to Procedure: Possible Action Taken: Clipping and Hospitalization Outcome: Recovered
Frequency: 1 affected / 66 at risk

Adverse event: Delayed Rectal Bleed
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Onset: Post Procedure / After Discharge Severity: Mild / Mild Relation EndoRotor: Possible / Probable Relation Procedure: Both Probable Action Taken: Both Hospitalization, observation, no intervention needed Outcome: Both Recovered
Frequency: 2 affected / 66 at risk

Adverse event: Single Arterial Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Onset: Procedure Severity: Severe Relationship EndoRotor: Not Related Relationship Procedure: Related Action Taken: clips and hospitalization Outcome: recovered
Frequency: 1 affected / 66 at risk

Adverse event: Delayed Bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Mediation, hospitalization, endoscopic hemostasis Recovered
Frequency: 1 affected / 66 at risk

Adverse event: General Infection
Serious: yes
Organ System: Infections and infestations
Notes: Onset: after discharge prior to 90 day follow-up Severity: moderate Relationship to EndoRotor: Not related Relationship to Procedure: Possible Action taken: Hospitalization and observation Recovered
Frequency: 1 affected / 66 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Onset: After discharge prior to 90 days Severity: Mild Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: Hospitalization Recovered
Frequency: 1 affected / 66 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Onset: After discharge prior to 90 days Severity: Severe Relationship to EndoRotor: Not related Relationship to Procedure: Not related Action taken: None Outcome: Death
Frequency: 1 affected / 66 at risk

Adverse event: Post Polypectomy Syndrome
Serious: no
Organ System: Gastrointestinal disorders
Notes: Onset: post procedure prior to discharge Severity: moderate Relationship to EndoRotor: not related Relationship to procedure: related Action taken: medication Recovered
Frequency: 1 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Onset: Post procedure prior to discharge Severity: mild Relationship to EndoRotor: not related Relationship to Procedure: not related Action: Medication Recovered
Frequency: 1 affected / 66 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Onset: Both Procedure Severity: Both mild Relationship to EndoRotor: Possible / Related Relationship to Procedure: Possible / Related Action: Hot biopsy / Clip Both recovered
Frequency: 2 affected / 66 at risk

Adverse event: Seeping bleed
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Onset: both procedure Severity: both mild Relationship to EndoRotor: both related Relationship to Procedure: both not related Action: both clips Both Recovered
Frequency: 2 affected / 66 at risk