| Class 2 Device Recall THUNDERBEAT | |
Date Initiated by Firm | September 27, 2013 |
Date Posted | December 05, 2013 |
Recall Status1 |
Terminated 3 on February 02, 2015 |
Recall Number | Z-0432-2014 |
Recall Event ID |
66407 |
510(K)Number | K111202 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip
TB-545FC: THUNDERBEAT 5 mm, 45 em, Front Actuated Grip
TB-0535FC: THUNDERBEAT 5 mm, 35 em, Front Actuated Grip
The Olympus Thunderbeat Surgical Tissue Management System ("Thunderbeat") is intended to be used for open, laparoscopic (including single-site surgery), and endoscopic surgery to cut (dissect) or coagulate soft tissue or to ligate (seal and cut) vessels. |
Code Information |
All sold units |
Recalling Firm/ Manufacturer |
Olympus America Inc. 3500 Corporate Pkwy. P.O. Box 610 Center Valley PA 18034-0610
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For Additional Information Contact | Customer Support 484-896-5688 |
Manufacturer 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. |
FDA Determined Cause 2 | Use error |
Action | 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. |
Quantity in Commerce | 8709 |
Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GEI
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