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Tuesday Poster Session
Category: Interventional Endoscopy
Nasir Saleem, MD
University of Tennessee Health Science Center
Indianapolis, IN, United States
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%) |