P2737 - Adverse Events Associated with the Use of FDA-Approved Innovative Duodenoscope Designs: An Analysis of Medical Device Reports (MDRs) from the Manufacturer and User Facility Device Experience (MAUDE) Database

Nasir Saleem, MD¹, Faisal Ali, MD², Faisal Kamal, MD³, Stuart Sherman, MD⁴, Mark Gromski, MD^4
1University of Tennessee Health Science Center, Indianapolis, IN; ²University of Texas Health Science Center at Houston, Chicago, IL; ³University of Tennessee Health Science Center, Memphis, TN; ⁴Indiana University School of Medicine, Indianapolis, IN

Introduction: Duodenoscopes, essential for performing ERCP procedures, have design features making reprocessing difficult. Infection transmission and outbreaks with resistant organisms have been linked to duodenoscopes. A concerted effort has been undertaken by healthcare institutions, professional societies, the FDA and device manufacturers to minimize the risk of infection transmission during ERCP. In August, 2019, the FDA recommended a transition to fully disposable duodenoscopes or those that have disposable components to enhance safety. The aim of this study is to assess reported adverse events for this category of innovative duodenoscopes.

Methods: Innovative duodenoscope designs were defined as FDA-approved single-use duodenoscopes or those with disposable distal tip components. We searched the FDA’s MAUDE database for medical device reports (MDRs) for innovative duodenoscopes from 1/1/2015 to 4/30/2021. We recorded the date of each report, nature of event, number of patients involved and any remedial action taken.

Results: A total of 300 reports were identified over the searched reporting period. The most common reported device was the Olympus TJF-Q190V duodenoscope with single use distal tip attachment, which made up 67.3% of all reports. The most common reporting source was device manufacturers (94%). For all reports, detachment of a device component made up 26.3% of reported events, while microbial contamination of the device (mostly on routine microbiological testing) made up 18.6% of reported events. None of the microbial contamination reports resulted in patient hospitalization. 77 (25.6%) reports involved tissue injury without perforation and 8 (2.6%) reports involved tissue injury with perforation.In 108 (36%) reports, the device was returned or evaluated by the manufacturer.

Discussion: An early analysis of MDRs from the MAUDE database suggests that there have been more MDRs reported to MAUDE for single-use component reusable duodenoscopes compared to single use duodenoscopes, with the most present for the Olympus TJF-Q190V device. Olympus has a majority market share, however, being the manufacturer of approximately 85% of duodenoscopes used in the US. Reportable events related to device dislodgment and tissue injury without perforation are currently most common, followed by microbial contamination. We anticipate as usage increases, there will be more events reported in the future, which will help further characterize safety and manufacturing concerns of these novel innovative devices.




Figure: Yearly breakdown of Medical Device Reports filed for FDA-Approved Innovative Duodenoscope Designs from the Manufacturer and User Facility Device Experience (MAUDE) database

Table 1. Characteristics of FDA MAUDE Reports Related to Innovative Design Duodenoscopes (N = 300)
Variable	N (%)
Device Make and Model (FDA clearance date)
Pentax Medical Duodenoscope Model ED34-i10T (9/20/2017)	15 (5.0%)
Fujifilm Corporation Duodenoscope Model ED-580XT (3/28/2019)	13 (4.3%)
Pentax Medical Duodenoscope Model ED34-i10T2* (11/15/2019)	47 (15.6%)
Boston Scientific Corporation, Duodenoscope EXALT Model D (12/13/2019)	23 (7.6%)
Olympus Medical Evis Exera III Duodenovideoscope Model TJF-Q190V† (1/17/2020)	202 (67.3%)
Ambu Innovation GmbH, aScope Duodeno (7/17/2020)	0 (0%)
Report Source
Manufacturer	282 (94.0%)
Distributor	16 (5.3%)
Voluntary healthcare personnel	2 (0.6%)
Report Issue
Device contamination with chemical or other material	4 (1.3%)
Component mis-assembly / Component incompatibility/ Loose or intermittent connection	3 (1.0%)
Detachment/ Dislodgement of device or device component	79 (26.3%)
Device malfunction/ Device break/ Mechanical problem	55 (18.3%)
Device reprocessing problem	15 (5.0%)
Microbial contamination of device	56 (18.6%)
Tissue injury with perforation	8 (2.6%)
Tissue injury without perforation	77 (25.6%)
Post-procedure cholangitis/pancreatitis/pneumonia	3 (1.0%)
Remedial Action (s)
Device not returned to manufacturer (some corrective action was undertaken)	163 (54.3%)
Device returned to manufacturer or evaluated by manufacturer	108 (36.0%)
Revision of Instructions for Use (IFU)	2 (0.6%)
No information available/unknown	27 (9.0%)

Table: Table 1. Characteristics of FDA MAUDE Reports Related to Innovative Design Duodenoscopes (N = 300)

*Including reports filed under model number OE-A63 for disposable endcap with elevator

†Including reports filed under model number MAJ-2315 for single-use distal cover




Disclosures:
Nasir Saleem indicated no relevant financial relationships.
Faisal Ali indicated no relevant financial relationships.
Faisal Kamal indicated no relevant financial relationships.
Stuart Sherman: Boston Scientific – Consultant. Cook – Consultant. Olympus – Consultant.
Mark Gromski: Boston Scientific – Consultant.


Nasir Saleem, MD¹, Faisal Ali, MD², Faisal Kamal, MD³, Stuart Sherman, MD⁴, Mark Gromski, MD⁴. P2737 - Adverse Events Associated with the Use of FDA-Approved Innovative Duodenoscope Designs: An Analysis of Medical Device Reports (MDRs) from the Manufacturer and User Facility Device Experience (MAUDE) Database, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.