BEUDAMED
    FDA Enforcement Class II Terminated

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    Recall: Z-2629-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2629-2017
    Event ID
    77297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2017
    Initiation Date
    April 19, 2017
    Classification Date
    June 26, 2017
    Termination Date
    October 1, 2018
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.

    Reason

    Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes.

    Code Info

    Model: A22201C - Resection electrode, loop style Lot # 16123P03L001, 16124P03L001, 16131P03L001, 16139P03L001, 16140P03L001, 16144P03L001, 16144P03L002, 16144P03L003, 16155P03L001, 16169P03L001,16173P03L001, 16174P03L001 16174P03L002, 16223P03L001,16224P03L001,16236P03L001 P16X0001, P16X0002,P16X0003,P16X0004,P16Y0001,P16Y0002 P16Y0003,P16Y0004,P16Y0005,P16Y0006,P16Y0007,P16z0001 P16Z0002,P16Z0003,P1710001,P1720001,P1720002 Model: WA22037C - Resection electrode, loop style Lot # 16195P04L001, 16215P04L001, P16Y0001

    Distribution

    Nationwide Distribution

    Quantity

    1264 units