Cheema Bakht S, Ghali Maged, Schey Ron, Awad Ziad, Ribeiro Bruno
Division of Gastroenterology, Department of Internal Medicine, University of Florida College of Medicine - Jacksonville, Jacksonville, Florida, USA.
Department of Surgery, University of Florida College of Medicine - Jacksonville, Jacksonville, Florida, USA.
Case Rep Gastroenterol. 2021 Dec 23;15(3):972-977. doi: 10.1159/000519685. eCollection 2021 Sep-Dec.
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.
美国食品药品监督管理局（FDA）最近发布了一份安全通告，建议转而使用具有创新设计的十二指肠镜，这种设计便于或无需再处理。因此，一次性十二指肠镜组件和一次性使用十二指肠镜有了大量发展，其触觉反馈各不相同。我们描述了一例使用一次性使用十二指肠镜（EXALT D型；美国波士顿科学公司，马尔伯勒，马萨诸塞州）后发生食管穿孔的病例。据我们所知，这是自2019年12月FDA批准该设备以来首次报告的食管穿孔病例。一名经验丰富的胃肠病学家使用EXALT D型一次性十二指肠镜（波士顿科学公司）进行了内镜逆行胰胆管造影术（ERCP）。在手术过程中，通过胃食管交界处施加的轻柔力量导致食管远端出现内衬穿孔。放置了食管支架，伤口愈合良好，未形成瘘管。在过去两年中有一些报告显示使用该设备取得了有前景的结果；然而，该设备在触觉反馈、导航和推进性方面的差异可能使其容易产生意外后果。
