Esophageal Perforation after Using a Single-Use Disposable Duodenoscope

Abstract

The Food and Drug Administration (FDA) has recently released a safety communication recommending transition to duodenoscopes with innovative designs that facilitate or eliminate the need for reprocessing. Thus, there has been a significant amount of development into disposable duodenoscope components and single-use duodenoscopes, with variable tactile feedback. We describe a case of esophageal perforation after using a single-use disposable duodenoscope (EXALT Model D; Boston Scientific Corporation, Marlborough, MA, USA). To our knowledge, this is the first reported case of an esophageal perforation since FDA approval of this device in December 2019. ERCP was performed with the EXALT Model D single-use duodenoscope (Boston Scientific Corporation) by an experienced gastroenterologist. During the procedure, gentle force applied through the gastroesophageal junction caused a liner perforation in the distal esophagus. An esophageal stent was placed with satisfactory wound healing and no fistula formation. There have been a few reports in the last 2 years showing promising results using this device; however, the differences in the tactile feedback, navigation, and pushability of the device may make it prone to unintended consequences.

Keywords

• biliary endoscopy
• diagnostic and therapeutic endoscopy
• endoscopic retrograde cholangiopancreatography
• disposable endoscopes
• duodenoscope reprocessing
• perforation
• complications