Z-0432-2014 Class II Terminated
FDA device recall Z-0432-2014 was initiated by Olympus America Inc. on September 27, 2013 and is designated Class II. 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. The recall status is terminated (terminated February 2, 2015). Affected quantity: 8709.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2013
- Initiation Date
- September 27, 2013
- Termination Date
- February 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8709
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
Code Information
All sold units