S1239 Adverse Events Associated With the CapsoCam Plus (SV-3)™ Capsule Endoscope: A Review of the FDA MAUDE Database

Introduction: CapsoCam Plus (SV-3)™ is a single-use, ingestible capsule endoscope that is used to visualize the small bowel. It uses 4 lateral cameras to capture a 360° view, surpassing other systems like PillCam SB3™, Endocapsule™, MicroCam™, and OMOM HD™ (156°–172°). Unlike other devices, CapsoCam stores images internally, which are retrieved after excretion. It was FDA-cleared in 2019 for remote ingestion under virtual medical supervision. Our study aimed to analyze reported adverse events related to the use of CapsoCam Plus (SV-3)™ using the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: We analyzed adverse events related to CapsoCam Plus (SV-3)™ reported in the FDA’s MAUDE database from January 2018 to July 2024. Reported claims were categorized into patient-related and device-related issues. A descriptive analysis of these claims was then performed. Results: A total of 18 events were identified: 15 device-related (83.3%) and 3 patient-related (16.7%). The most common device related adverse event was capsule retention (n = 14, 77.7%). Of these, 4 were removed via colonoscopy, 1 with double balloon enteroscopy, 3 with esophagogastroduodenoscopy, and 6 required surgical removal. Two surgical cases followed failed double balloon retrievals. Seven of the retention events (n = 7, 50%) occurred in patients with pre-existing gastrointestinal (GI) conditions: Crohn’s disease (n = 4), ulceration from carcinoid tumor (n = 1), prior mucosal banding (n = 1), and a stricture within a ventral hernia (n = 1, 6.67%). One case of device fragmentation was reported with spontaneous excretion that did not require intervention. All patient-related events (n = 3, 22.3%) involved bowel obstruction: 2 in the small bowel, 1 unspecified. All 3 patients required surgery, including 1 exploratory laparotomy. One patient had been treated with 4 types of laxatives before surgery. Conclusion: CapsoCam Plus (SV-3)™ is a newly approved device for small bowel visualisation. Capsule retention is the most common device related problem, particularly in patients with underlying GI pathology. This highlights that capsule retention continues to be a significant issue across video capsule endoscopy devices. Future efforts should focus on innovative techniques to improve capsule design to reduce retention risk in patients.