Esophageal Perforation after Using a Single-Use Disposable Duodenoscope.

Area of Science:

• Gastroenterology and Endoscopy
• Medical Device Safety

Background:

• The Food and Drug Administration (FDA) recommends duodenoscopes that minimize reprocessing needs.
• Development of single-use duodenoscopes aims to enhance patient safety and reduce infection risks.
• The EXALT Model D is a single-use duodenoscope approved by the FDA.

Observation:

• A case of esophageal perforation during Endoscopic Retrograde Cholangiopancreatography (ERCP) using the EXALT Model D single-use duodenoscope is reported.
• The perforation occurred in the distal esophagus due to gentle force at the gastroesophageal junction.
• This is the first reported esophageal perforation with this specific device since its FDA approval.

Findings:

• The patient underwent successful esophageal stent placement with good healing and no fistula.
• The single-use duodenoscope, while offering safety benefits, may present unique challenges.
• Differences in tactile feedback and device handling compared to reusable models might contribute to adverse events.

Implications:

• This case underscores the need for careful evaluation of new disposable duodenoscopes.
• Endoscopists should be aware of potential risks, including esophageal perforation, with novel devices.
• Further research is needed to optimize the design and usability of single-use duodenoscopes to ensure patient safety.