Class 2 Device Recall Soltive SuperPulsed Laser System

• Date Initiated by Firm: May 31, 2024
• Date Posted: August 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2504-2024
• Recall Event ID: 94964
• 510(K)Number: K221306
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: Soltive Premium SuperPulsed Laser System, Model TFL-PLS
• Code Information: Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.
• FEI Number: 2429304
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: Cynthia Ow; 647-9993203
• Manufacturer Reason for Recall: Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
• FDA Determined Cause: Device Design
• Action: On 06/28/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of these products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use, including instructions related to connecting the wireless footswitch. 4. Olympus requests that you acknowledge receipt of this letter. 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 "0448 c. Complete the form as instructed and include your account ID number. d. Indicate in the comments if your facility does not have a wired footswitch. Olympus Customer Service will contact you to make arrangements for a wired footswitch. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including failure of the wireless footswitch pairing with the Soltive Laser System, or any associated injuries to the 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. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 from Monday through Friday or by e-mail Cynthia.Ow@olympus.com.
• Quantity in Commerce: 1,585 Units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.
• 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