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U.S. Department of Health and Human Services

Class 2 Device Recall AMS GreenLight PV Surgical Laser System

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 Class 2 Recall
AMS GreenLight PV Surgical Laser System
see related information
Date Posted February 14, 2011
Recall Status1 Terminated on February 14, 2011
Recall Number Z-1229-2011
Recall Event ID 56058
Premarket Notification
510(K) Number
K010284 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product 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.
Code Information All units of the model.
Recalling Firm/
Manufacturer
AMS Innovative Center - San Jose
3070 Orchard Dr
San Jose, California 95134-2011
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Alberto Sanchez
408-943-0636 Ext. 6703
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 CustomerCare@ammd.com.
Quantity in Commerce ~242,000 units
Distribution Worldwide Distribution including US
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LASERSCOPE
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