FDA-Device2025-01-29Class II

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).

Olympus Corporation of the Americas
Hazard

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

Sold states
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.
Affected count
495,865 units (96,253 US, 399,612 OUS)
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2025

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