Olympus Corporation of the Americas: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

Agency Publication Date: August 4, 2023

Affected Products

Product: VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

UDI-DI: 04953170340246 All serial numbers

Product: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube

UDI-DI: 04953170051098 All serial numbers

Product: Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

UDI-DI: 04953170258589 All serial numbers

Product: Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

UDI-DI:- 04953170331619 Serial Numbers: 2300314 and the last three digits less than 314

Product: Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.

UDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92633

Status: Active

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 5 products (1433 units; 686 units; 4244 units; 241 units; 1063 units)

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Sources: FDA iRES · Raw API Response

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