Events

Recall of THUNDERBEAT

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus America Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0432-2014
  • Event Date Posted
    2013-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122340
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 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.
  • 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.

Device

THUNDERBEAT
  • Model / Serial
    All sold units
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally to Canada.
  • 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.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA