Washer, Cleaner, Automated, Endoscope
FDA adverse event reports and recall history for washer, cleaner, automated, endoscope (product code NVE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 264
- Deaths
- 0
- Injuries
- 21
- Malfunctions
- 233
Reports per year
Source: FDA adverse event reports by year received, 2006–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2016-07-06TerminatedProcess control
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.
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