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Reported Adverse Events

Several adverse events have reported as below. (August – December 2019)

In order to improve your routine procedural quality, please carefully see and understand.

Case 1

Adverse Event Bowel perforation
Location NA
Age, gender, and body measurements NA
Patient’s condition Crohn’s disease
(Diagnosed via exam)
Insertion direction Retrograde
Anesthesia NA
Experts’ comments
  • Safety unknown for known stricturing diseases such as Crohn’s disease: Perform exam only when benefits outweigh risks.
Relevant information link 2-4 Precautions

Case 2

Adverse Event

  • Esophageal tear
  • Esophageal perforation
Location NA
Age, gender, and body measurements NA
Patient’s condition Dysphagia
Insertion direction Antegrade
Anesthesia NA
Experts’ comments
  • Safety unknown for history of dysphagia and esophageal stricture: Perform exam only when benefits outweigh risks.
  • All patients with a history of dysphagia should undergo a formal evaluation which includes an EGD before performing PowerSpiral.
Relevant information link 2-4 Precautions

Case 3

Adverse Event Ileal perforation
Location Terminal ileum
Age, gender, and body measurements 81-year-old, Female, 158cm, 58kg, BMI:23.2
Patient’s condition
  • Small intestine bleeding
  • Diverticulosis
Insertion direction Retrograde
Anesthesia Deep sedation
Experts’ comments
  • Continuous rotation in the same location may result in bowel injury with mucosal disruption, bleeding, and deeper injury with perforation, especially within the terminal ileum.
  • Repositioning the patient and the scope or adding manual abdominal compression if no advancement is achieved. If the rotating power segment is in the same position, this should be a warning to assess continuing efforts or
    terminating the procedure.
Relevant information link 4-1 General Techniques
4-2 Insertion Tips

Case 4

Adverse Event
  • Superficial esophageal tear
  • Small esophageal perforation
Location Upper esophagus
Age, gender, and body measurements 50-year old, Female, 173cm, 51kg, BMI:17.0</
Patient’s condition
  • Tight upper esophageal sphincter
  • No past medical history of dysphagia
Insertion direction Antegrade
Anesthesia GA
Experts’ comments
  • Patient’s thin body habitus (BMI 17.0) may be problematic for scope intubation.
  • Confirmation of PowerSpiral insertion accommodation using a bougie (54-60Fr) is highly recommended, especially in early experience (first 10 cases).
  • If passage into the esophagus remains difficult, repositioning of the patient’s position and use of head and neck repositioning by the anesthesiologist or anesthetist may be useful.
Relevant information link

4-2 Insertion Tips

4-3 Withdrawal Tips
4-4 Antegrade Approach Note
5-1 Emergency Withdrawal

Case 5

Adverse EventSevere mucosal injury in proximal esophagus

Location Proximal esophagus
Age, gender, and body measurements 78-year-old, Female, 160cm, 71kg, BMI:27.7
Patient’s condition
  • The proximal esophagus may have been less relaxed
  • No past medical history of dysphagia
Insertion direction Antegrade
Anesthesia Deep sedation
Experts’ comments
  • Pre-intubation bougie dilation useful if there is any resistance to intubation
  • General anesthesia may provide more complete muscle relaxation
  • Neck positioning is important
Relevant information link 4-2 Insertion Tips
4-3 Withdrawal Tips
4-4 Antegrade Approach Note
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