—#210101

Product

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: 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: UDI 00821925044111 All Serial Numbers:

Why it was recalled

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Olympus issued Urgent Medical Device Correction Letter on 9/12/24 to Operating Room Director, Risk Management. Letter states reason foe recall, health risk and action to take: 1. Carefully read the content of this notification. 2. Please check all areas of your facility to determine if you have the devices specified above. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use. 4. If you have further distributed this product, identify your customers, and forward them this notification. 5. Olympus requests that you acknowledge receipt of this letter through our recall web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number: "0452 c. Complete the form as instructed. If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com or by phone at (647) 999-3203

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 AU, CA, CL, DE, HK, JP, SG.

Timeline

Recall initiated: 2024-08-13
Posted by FDA: 2024-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.