BEUDAMED
    FDA Recall Open, Classified

    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

    Recall: Z-1238-2025 · Initiated January 29, 2025

    Recall

    Recall Number
    Z-1238-2025
    Event Number
    96164
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    PEA
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 29, 2025
    Posted
    February 26, 2025
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c

    Reason

    During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.

    Action

    Pentax issued URGENT i20c Endoscope User Notification-Precautions when using PENTAX Medical i20c endoscopes with EPK-i8020c Processor Letter on 1/29/25 certified USPS Mail. The letter states reason for recall, health risk and action to take: Customer Instructions: Perform a pre-use inspection according to the Instructions for Use to make sure that there are no foreign objects, scratches, chips, or other abnormalities on the light guide. Do not use OE (Optical Enhancement) mode in cases where there is bleeding such as hematemesis or hematochezia, or where a lot of bleeding was observed during an endoscopic examination or procedure. Use normal observation mode and set the illumination brightness to the minimum necessary. If you notice any abnormalities, such as the observed image being reddish or darker than normal, discontinue use and immediately remove the endoscope from the patient while keeping the endoscope at a distance from the mucous membrane. The temperature at the tip of the endoscope could rise and may cause thermal injury to the patient's mucous membranes. After removing the endoscope, turn off the video processor lamp. Check the distal end of the endoscope, remove any attached patient material, and confirm that the light guide is normal before using it again. If you cannot completely remove all patient material from the distal end of the endoscope, discontinue use and contact PENTAX Medical service facility and request repairs. Please download the Instructions for use (IFU) from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com for the following products: Models EPK-i8020c; EC38-i20cL; EG29-i20c. Further Actions by PENTAX Medical: PENTAX Medical is currently considering countermeasures that will help to further reduce the potential risks mentioned above. PENTAX Medical will duly notify you when we are ready to implement the changes. Contact Information: Please indicate through the attached response form that you have received and

    Distribution

    Nationwide

    Quantity

    94 units