FDA Medical Device Recalls (openFDA)
Olympus America Inc.: 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.
- Recall number
- Z-0432-2014
- Recalling firm
- Olympus America Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-09-27
- Posted
- 2013-12-05
- Terminated
- 2015-02-02
- Reason
- 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.
- Root cause
- 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
- 8709
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
- Lot, serial or model codes
- All sold units
- 510(k) numbers
- ["K111202"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28