My question involves medical malpractice in the state of: Colorado
I am not certain if this was malpractice or a device failure. The device used is called SeedNet and is manufactured by Galil. It is a cryotherapy device used for prostate cancer treatment among other things. It appears that the procedure was successful but the patient suffered frostbite injury to the perineum tissue requiring debridement. This device uses very thin probes which are inserted through the perineum and positioned by the tumor using ultrasound imaging. When actrivated, the tip of the probe becomes very cold forming an ice ball surrounding the tumor. The upper part of the probe which passes through the perineum tissue is not supposed to get cold. Apparently it did causing frostbite injury. I finally received a copy of the SeedNet manual which does not appear to address this issue at all. This type of injury is not listed in any publication I have seen as a possible side effect of this type of surgery. A search of the FDA database turned up two incidents which sound very similar. However, the reports were written by the manufacturer and provide very little information other than to absolve the device of any fault. I am having a difficult time finding anyone who has knowledge of the use of this device and by what mechanism it can cause injury to non-target tissue. So far, the manufacturer denies that their device even caused the injury. The doctor who performed the surgery has done it a hundred times without ever having this problem. Accordingly, she believes there was an equipment malfunction of some sort. Does anyone have any info?

