P0226 - Analysis of Reported Adverse Events Related to the Use of Distal Colonoscopy Attachments Devices: A Retrospective Review of an FDA MAUDE Database Study

Khalid Ahmed, MD¹, Shaikhoon Mohammed, MD², Abdellatif Ismail, MD³, Ayman Elawad, MD⁴, Elmkdad E. Mohammed, MD⁵, Mohanad Awadalla, MD⁶, Marwa Salman, MBBS⁷, Mohammad Adam, MD, MSc⁸, Azizullah Beran, MD⁹, Mohamed Abdallah, MD¹⁰, Mohammad Bilal, MD^11
1University of Pennsylvania, Philadelphia, PA; ²Macon Medical Group PC, Atlanta, GA; ³University of Maryland Medical Center, Baltimore, MD; ⁴Massachusetts General Hospital, Boston, MA; ⁵The Wright Center for Graduate Medical Education, Scranton, PA; ⁶Beth Israel Deaconess Medical Center, Boston, MA; ⁷University of Medical Sciences and Technology, Khartoum, Sudan, Philadelphia, PA; ⁸University of Missouri - Kansas City School of Medicine, Kansas City, MO; ⁹Indiana University School of Medicine, Indianapolis, IN; ¹⁰Cleveland Clinic, Cleveland, OH; ¹¹University of Minnesota and Minneapolis VA Health Care System, Minneapolis, MN

Introduction: Distal attachment devices are useful tools that can be attached to the distal end of a colonoscope to improve visualization of mucosa during colonoscopy and can improve adenoma detection rate (ADR). Endocuff™ and Endoring™ are approved by the FDA for this purpose However, there is limited information regarding any adverse events (AE) with these devices. This study aims to investigate the reported adverse events and device failures related to these distal attachment devices, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA).

Methods: We analyzed the post-marketing surveillance data from the FDA’s MAUDE database for these distal attachment devices from June 2015 through May 2024. The results of the search were classified into patient-related adverse events and device-related problems.

Results: A total of nineteen claims for these distal attachment devices were found, and six were duplicates, leaving a total thirteen for analysis. There were twelve device-related problems and one patient-related adverse event. Claims involved Endoring™ (n=10, 76.9%) and Endocuff™ (n=3, 23.1%). All device-related problems with Endoring™ were due to device detachments, and all detached devices were retrieved (n=9, 100%) (Table 1). The most common sites of detachment were the sigmoid colon (n=5, 55.6%), rectum (n=2, 22.2%), and unspecified (n=2, 22.2%). The primary reasons for Endoring™ detachments were size mismatch between the device and colonoscope (n=4, 44.4%), ‘tight’ sigmoid colon (n=1, 11.1%), and unspecified (n=4, 44.4%). Regarding the Endocuff™ device, all device-related problems were reported as device breaks and all devices were retrieved (n=3, 100%). Two devices were retrieved by using forceps while the other used an unspecified device. An adverse event with Endoring™ involved a patient with severe diverticular disease and prior abdominal surgeries, who developed a perforation treated laparoscopically. The physician attributed the perforation to the patient’s severe diverticular condition and previous hysterectomy.

Discussion: While these devices are generally safe, future iterations of these devices should focus on improvement in design to decrease the rate of device detachment and breakage. In addition, these devices should be used with caution in patients with severe diverticular disease, colonic strictures, or a history of abdominal surgeries.


Disclosures:


Khalid Ahmed, MD¹, Shaikhoon Mohammed, MD², Abdellatif Ismail, MD³, Ayman Elawad, MD⁴, Elmkdad E. Mohammed, MD⁵, Mohanad Awadalla, MD⁶, Marwa Salman, MBBS⁷, Mohammad Adam, MD, MSc⁸, Azizullah Beran, MD⁹, Mohamed Abdallah, MD¹⁰, Mohammad Bilal, MD¹¹. P0226 - Analysis of Reported Adverse Events Related to the Use of Distal Colonoscopy Attachments Devices: A Retrospective Review of an FDA MAUDE Database Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.