Recall Z-0432-2014 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
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
| Date | Dec 5, 2013 (initiated Sep 27, 2013) |
| Status | Terminated |
| 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 ad |
| Quantity | 8709 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111202 | SURGICAL TISSUE MANAGEMENT SYSTEM Olympus Medical Systems Corp., Jan 20, 2012 |