Thunderbeat Instrument Grips (Pistol and Inline) and Thunderbeat… — recall 50545
Health Canada — Medical Devices · Canada · 2013-10-25 · Type III
As described by Health Canada — Medical Devices: Thunderbeat Instrument Grips (Pistol and Inline) and Thunderbeat Front-Actuated Grip (2013-10-02)
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Archived by the issuing authority — kept for reference
Reported risk: 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.
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