Events

Recall of Device Recall OptiLITE MultiUse Holmium Laser Fiber

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Xintec Corp.

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
    77653
  • Event Risk Class
    Class 2
  • Event Number
    Z-2866-2017
  • Event Initiated Date
    2017-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157183
  • 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
    It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. the preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.
  • Action
    The firm, Convergent Laser Technologies, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 06/23/2017 to its Consignees. The letter described the product, problem and actions to be taken. The consignees were instructed as follows: "Please immediately review your inventory and quarantine any affected product. Please return any affected products within 30 days according to the instructions provided in the attached Acknowledgement and Receipt Form. Upon receipt of the product and response form, we will arrange for a credit to your account. Also, whether or not you are returning any affected product, please send a copy of the Acknowledgement and Receipt Form to our Regulatory Department via fax at 510-832-1600 or via e-mail to regulatory@convergentlaser.com." If you have any further questions or concerns, please contact our Customer Service Department at 510-832-2130 or 800-848-8200.

Device

Device Recall OptiLITE MultiUse Holmium Laser Fiber
  • Model / Serial
    all codes.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.
  • Product Description
    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES || The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.
  • Manufacturer
    Xintec Corp

Manufacturer

Xintec Corp
  • Manufacturer Address
    Xintec Corp, 1660 S Loop Rd, Alameda CA 94502-7091
  • Manufacturer Parent Company (2017)
    Xintec Corporation
  • Source
    USFDA