Events

Recall of THUNDERBEAT FRONT-ACTUATED GRIP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    66535
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Olympus has received customer complaints on the deterioration of the thunderbeat probe during surgical procedures. these complaints involve a combination of the following descriptions - the generation of audible and visual generator alarms the deformation of the components of the thunderbeat probe tip or jaw or the detaching of a fragment from the thunderbeat probe tip or jaw. olympus has investigated these complaints and the manufacturer has determined that improvements to the labeling for surgical technique including recommendations for best practices in cutting and dissection techniques during laparoscopic hysterectomy are appropriate to reduce/eliminate these complaints associated with device use.

Device

THUNDERBEAT FRONT-ACTUATED GRIP
  • Model / Serial
    Model Catalog: TB-0545FC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535FC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0545PC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535PC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0510IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0535IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0520IC (Lot serial: > 10 numbers contact mfg.); Model Catalog: TB-0545IC (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    THUNDERBEAT FRONT-ACTUATED GRIP
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.