P0850 - Adverse Events Associated With the CapsoCam Plus (SV-3)™ Capsule Endoscope: A Review of the FDA MAUDE Database

Elmkdad Mohammed, MD¹, Seyma Bayram, MD¹, Sunny Kumar, MD², Eiman Mohammed, MBBS³, Mohammad Adam, MD, MSc⁴, Marwa Salman, MBBS⁵, Khalid Ahmed, MD⁶, Ahmed Dirweesh, MD⁷, Mohammad Bilal, MD, FACG⁸, Mohamed Abdallah, MD⁹
1The Wright Center for Graduate Medical Education, Scranton, PA; 2Wright Center for Graduate Medical Education, Scranton, PA; 3university of Khartoum, Scranton, PA; 4University of Missouri - Kansas City School of Medicine, Kansas City, MO; 5University of Medical Sciences and Technology, Minneapolis, MN; 6University of Minnesota, Minneapolis, MN; 7University of Minnesota Medical Center, Minneapolis, MN; 8University of Colorado Anschutz Medical Campus, Denver, CO; 9Corewell Health, Royal Oak, MI

Introduction: CapsoCam Plus (SV-3)™ is a single-use, ingestible capsule endoscope that is used to visualize the small bowel. It uses four 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, four were removed via colonoscopy, one with double balloon enteroscopy, three with esophagogastroduodenoscopy, and six 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: two in the small bowel, one unspecified. All three patients required surgery, including one exploratory laparotomy. One patient had been treated with four types of laxatives before surgery

Discussion: 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

Disclosures:
Elmkdad Mohammed indicated no relevant financial relationships.
Seyma Bayram indicated no relevant financial relationships.
Sunny Kumar indicated no relevant financial relationships.
Eiman Mohammed indicated no relevant financial relationships.
Mohammad Adam indicated no relevant financial relationships.
Marwa Salman indicated no relevant financial relationships.
Khalid Ahmed indicated no relevant financial relationships.
Ahmed Dirweesh indicated no relevant financial relationships.
Mohammad Bilal: Boston Scientific – Consultant. Cook endoscopy – Paid speaker. Steris Endoscopy – Consultant.
Mohamed Abdallah indicated no relevant financial relationships.

Elmkdad Mohammed, MD¹, Seyma Bayram, MD¹, Sunny Kumar, MD², Eiman Mohammed, MBBS³, Mohammad Adam, MD, MSc⁴, Marwa Salman, MBBS⁵, Khalid Ahmed, MD⁶, Ahmed Dirweesh, MD⁷, Mohammad Bilal, MD, FACG⁸, Mohamed Abdallah, MD⁹. P0850 - Adverse Events Associated With the CapsoCam Plus (SV-3)™ Capsule Endoscope: A Review of the FDA MAUDE Database, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.