Events

Recall of Device Recall AMS GreenLight PV Surgical Laser System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AMS Innovative Center - San Jose.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56058
  • Event Risk Class
    Class 2
  • Event Number
    Z-1229-2011
  • Event Initiated Date
    2010-02-08
  • Event Date Posted
    2011-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92557
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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 CustomerCare@ammd.com.

Device

Device Recall AMS GreenLight PV Surgical Laser System
  • Model / Serial
    All units of the model.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including US
  • Product 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.
  • Manufacturer
    AMS Innovative Center - San Jose

Manufacturer

AMS Innovative Center - San Jose
  • Manufacturer Address
    AMS Innovative Center - San Jose, 3070 Orchard Dr, San Jose CA 95134-2011
  • Source
    USFDA