The FDA ( Food and Drug Administration ) has received reports of patient deaths associated with lung tumor ablation using radio frequency ( RF ) ablation devices, and similar reports have appeared in the literature.
Patient selection, subsequent treatment, and technical use of the RF device, including placement and operation, may have contributed to the fatalities.

FDA has cleared many RF ablation devices as tools for general ablation of soft tissue by thermal coagulation necrosis. These devices have also been cleared for certain specific indications, including partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone.
It is important to note that they have not been cleared specifically for lung tumor ablation.

Healthcare professionals should use caution when operating RF ablation devices, adhering strictly to information contained in the labeled operating instructions, Operators Manual, the Manufacturer's Instructions for Use and any training provided.
Additionally, if healthcare professionals plan to use RF ablation devices to treat patients with lung tumors, they should consider enrolling patients in an approved clinical study, where training is available.

In February 2003, FDA’s General and Plastic Surgery Devices Advisory Committee’s discussed the subject of thermal ablation of lung tumors. Concerns were raised about the safety and adverse event reporting associated with RF ablation of lung tumors.

Source: FDA, 2007

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