BEUDAMED
    FDA Recall Open, Classified

    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

    Recall: Z-0748-2024 · Initiated December 1, 2023

    Recall

    Recall Number
    Z-0748-2024
    Event Number
    93649
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 1, 2023
    Posted
    January 18, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS

    Reason

    Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

    Action

    On December 1, 2023, the firm issued URGENT MEDICAL DEVICE CORRECTION letters to affected customers. Customers were provided with copies of the labeling addendum to add to remaining inventory. Customers may continue to use the product, but this should be done in accordance with the labeling addendum. If you require additional information, please contact Olympus at (647) 999-3203 or at [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Europe, Hong Kong, Australia, Japan, Singapore, and Latin America.

    Quantity

    82,200 total units (5 per box)