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U.S. Department of Health and Human Services

Class 2 Device Recall OptiLITE MultiUse Holmium Laser Fiber

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  Class 2 Device Recall OptiLITE MultiUse Holmium Laser Fiber see related information
Date Initiated by Firm June 23, 2017
Create Date August 02, 2017
Recall Status1 Terminated 3 on June 20, 2018
Recall Number Z-2866-2017
Recall Event ID 77653
510(K)Number K992866  
Product Classification Powered laser surgical instrument - Product Code GEX
Product 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.
Code Information all codes.
Recalling Firm/
Manufacturer		 Xintec Corp
1660 S Loop Rd
Alameda CA 94502-7091
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Labeling False and Misleading
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.
Quantity in Commerce 4343 units
Distribution Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = CONVERGENT LASER TECHNOLOGIES
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