BEUDAMED
    FDA Recall Terminated

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    Recall: Z-0138-2017 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-0138-2017
    Event Number
    74542
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FEB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 23, 2016
    Posted
    October 19, 2016
    Terminated
    January 26, 2017
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

    Reason

    New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.

    Action

    Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor. The following actions were asked to be taken: -Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. - Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals. - Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80. - Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection. - Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128.

    Distribution

    Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY

    Quantity

    2, 686 units