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: N5423330 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).
This recall is currently active, issued January 21, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- November 25, 2024
- Posted
- January 21, 2025
- Recall Number
- Z-0998-2025
- Quantity
- 9,200 units (OUS ONLY)
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Distribution
US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepale, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Utd.Arab Emir., Vietnam, Yemen.
Lot / Code Info
Model: TB-0545FCS; Catlog Number/Product Code: N5423330; UDI: 04953170383519, 04953170383516; Lots: All
Root Cause
Under Investigation by firm
Action Taken
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.