Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-ac
FDA device recall Z-1000-2025 · posted 2025-01-21 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LFL
- Quantity affected
- 112 units (OUS ONLY)
- Distribution
- US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Camb
- Date initiated
- 2024-11-25
- Date posted
- 2025-01-21
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ultrasonic Bipolar Generator USG-410 with accessories (K211838) | Olympus Medical Systems Corporation | 2021-08-04 |