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U.S. Department of Health and Human Services

Class 2 Device Recall Soltive SuperPulsed Laser System

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  Class 2 Device Recall Soltive SuperPulsed Laser System see related information
Date Initiated by Firm December 04, 2023
Date Posted January 12, 2024
Recall Status1 Open3, Classified
Recall Number Z-0716-2024
Recall Event ID 93613
510(K)Number K183647  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Code Information Lot Number: All units sold prior to 2023
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
FDA Determined
Cause 2		 Under Investigation by firm
Action An URGENT: MEDICAL DEVICE REMOVAL notification letter dated 12/4/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has received one or more affected units. Olympus requests you to take the following actions: 1. Examine your inventory and quarantine any devices with the lot number specified above. 2. Please contact Olympus customer service representative at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall. b. Enter the recall number "0435 c. Complete the form as instructed. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including product labeling issues, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.
Quantity in Commerce 3001 units
Distribution US Nationwide. Global Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = Olympus Surgical Technologies America
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