TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT
FDA device recall Z-0432-2014 · posted 2013-12-05 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw.
- Action taken
- Olympus sent an Urgent Medical Device Field Correction Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the actions needed to be taken by the customer. Please make the attached Procedural Tips and Techniques instructions available to all users of the THUNDERBEAT hand instruments. Please also maintain a copy with the Instruction Manual(s) fot"the device. OCA requires that you indicate on the enclosed questionnaire your acknowledgement of receipt of this corrective action and the contact information for your facility. This additional user instruction is also being added to the Instruction Manual(s) for the THUNDERBEAT hand instruments. If you would like a copy of the updated Instruction Manual(s), please contact OAI Customer Service at 1-800-848-9024. For further questions please call (484) 896-5688.
- Root cause
- Use error
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 8709
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
- Date initiated
- 2013-09-27
- Date posted
- 2013-12-05
- Date terminated
- 2015-02-02
- 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 |
|---|---|---|
| SURGICAL TISSUE MANAGEMENT SYSTEM (K111202) | Olympus Medical Systems Corp. | 2012-01-20 |