Recalls / —

—#208981

Product

Soltive Premium SuperPulsed Laser System, Model TFL-PLS

FDA product code

GEX — Powered Laser Surgical Instrument

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K221306

Affected lot / code info

Model: TFL-PLS; UDI-DI: 00821925044111; Serial Numbers: All Serial Numbers.

Why it was recalled

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Timeline

Recall initiated

2024-05-31

Posted by FDA

2024-08-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #208981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.