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.
FDA Recall Z-1229-2011 · Posted 2011-02-14
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Recalling FirmAMS Innovative Center - San Jose
Recall StatusTerminated
Product CodeGEX
Date Initiated2010-02-08
Date Terminated2011-02-14
Product Quantity~242,000 units
Reason for Recall
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.
Firm 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].
Root Cause
Other
Distribution Pattern
Worldwide Distribution including US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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