Thunderbeat Instrument Grips (Pistol and Inline) and Thunderbeat Front-Actuated Grip (2013-10-02)

Starting date:

October 2, 2013

Posting date:

October 25, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36393

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  Reason
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  Affected products

Recalled products

1. Thunderbeat Instrument - Pistol Grip
2. Thunderbeat Instrument - Inline Grip
3. Thunderbeat Front-Actuated Grip

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 claims 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.

Affected products