Olympus Duodenovideoscope Recalled Due to Increased Microbial Contamination
Olympus Corporation recalls approximately 12,195 EVIS EXERA III Duodenovideoscopes (Model TJF-Q190V) worldwide. Post-market surveillance data suggests higher microbial contamination levels when manual cleaning is delayed beyond one hour and a presoak is performed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving microbial contamination in a medical device used in patient procedures, with no reported illnesses or injuries. Per the severity rubric, a risk-of-harm product where injury has not yet been reported warrants a score of 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus EVIS EXERA III Duodenovideoscope, Model Number TJF-Q190V, a medical device used in diagnostic and therapeutic procedures. Approximately 12,195 units have been distributed worldwide, including throughout the United States and to numerous international locations.
Post-market surveillance data suggests a possible association between higher microbial contamination levels and delayed manual cleaning procedures. The data indicates that TJF duodenoscopes showed elevated contamination levels when manual cleaning was delayed beyond one hour following patient use and a presoak was performed, compared to devices where manual cleaning began within one hour after the procedure.
Affected healthcare facilities should contact Olympus Corporation of the Americas for instructions regarding the recall and proper device reprocessing procedures.
The recalled product
- Product
- Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- microbial-contamination
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Distribution
Distributed nationwide across the United States.
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