Olympus Corporation Of The Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Nam…

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N5423510 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).

On December 20, 2024, URGENT FIELD SAFETY NOTICE: ADVISORY letters were sent to customers. Actions Required: Olympus requires you to take the following actions: 1. Carefully read the content of this FSN. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this FSN and the relevant IFU. 3. Olympus requests that you acknowledge receipt of this FSN through our web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0462 c. Complete the form as instructed and include your account ID number: [XXXXXXXX] d. Indicating in the comments if you would like to receive in-service training to support the correct use of this device. 4. If you have further distributed this product, identify your customers, and forward this FSN to them. Olympus requests that you report any complaints, including probe damage or pad detachment, to 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 by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.

• FDA enforcement recordOfficial FDA database entry for Z-1000-2025
• FDA 510(k) clearance · K211838The device's official FDA premarket clearance record
• FDA device classification · LFLOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.