Thunderbeat Surgical Instrument (Olympus) – Probe Tip Damage (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 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).
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model Number: TB-0535FCS, Catalog Number/Product Code: R5000687, UDI: 04953170409677 and 04953170383540, Lots: All
Products Sold
Model Number: TB-0535FCS; Catalog Number/Product Code: R5000687; UDI: 04953170409677 and 04953170383540; Lots: All
Olympus Corporation of the Americas is recalling Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT due to The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026