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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 Event	Severe 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

Content Type

Procedure Guide