BEUDAMED
    FDA Recall Terminated

    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.

    Recall: Z-1229-2011 · Initiated February 8, 2010

    Recall

    Recall Number
    Z-1229-2011
    Event Number
    56058
    Firm
    AMS Innovative Center San Jose
    FEI Number
    2937094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 8, 2010
    Posted
    February 14, 2011
    Terminated
    February 14, 2011
    Address
    3070 Orchard Dr, San Jose, CA, 95134-2011

    Description

    AMS brand GreenLight PV Laser System, Model-P/N: 0010-9230; Product is manufactured and distributed by AMS Solutions, San Jose, CA The GreenLight Surgical Laser System and accessories are intended for use in endoscopic (cystscopic) KTP 532 nm laser resection of the prostate for the treatment of benign prostatic hyperplasia (BPH). The entire laser unit and controls are contained in a single console that is connected to external electricity and water sources. Fibers are sterile, single-use, disposable fiber optic delivery systems, designed to deliver 532nm laser energy, the fiber is connected to the laser console and used to cut, coagulate and vaporize prostate tissue.

    Reason

    A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.

    Action

    AMS Innovative Center - San Jose issued Important Product Update Information letters via express mail on February 8, 2010, and September 15, 2010 to all its direct consignees. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to attach the Fiber Guard to their GreenLight PV Laser System, and to complete the Response Form in the enclosed, self-addressed, postage paid envelope to AMS. For any questions regarding this recall call the Customer Care Department at 1-800-356-7600 or send an e-mail to [email protected].

    Distribution

    Worldwide Distribution including US

    Quantity

    ~242,000 units