Recall Z-1001-2025 ยท LFL Instrument, Ultrasonic Surgical
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423930 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
| Date | Jan 21, 2025 (initiated Nov 25, 2024) |
| Status | Open, Classified |
| Reason | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Root cause | Under Investigation by firm |
| Action | 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 co |
| Quantity | 84,570 units (4489 US, 80081 OUS) |
| 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, Dom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories Olympus Medical Systems Corporation, Aug 4, 2021 |