[1102249]
Hello; i would like to register a complaint regarding the eksell gamma knife product that was used by the neurology department in june 2007 for the attempted removal of my brain lesion. This complaint is a function of both an adverse event and a product use error at the facility, that resulted in a potentially life-threatening situation for me. Briefly, in 2007, i had gamma knife brain surgery to repair a brain lesion that had been causing me to have gran mal seizures. Unfortunately, the surgery did not go as planned. First, the radiation material in the equipment was significantly depleted and this resulted in the procedure taking 8 hours instead of the 2 hours expected by the attending neurosurgery. Second, in the middle of the surgery and at a critical point, the gamma knife equipment broke down, and this dangerous and life-threatening situation was compounded exponentially because the neurosurgeon in charge had in fact left the building. He had actually gone home and left the remainder of his brain surgery procedure in the hands of a radiologist. So the equipment breakdown was the adverse event and the product use error was a result of the extremely lax gamma knife surgery procedures and safeguards at ucsf. When this equipment mal-functioned occurred, panic and chaos ensued because in the surgeon's absence no one was in charge with the requisite neurology skills, knowledge or leadership. Only the radiologist. My wife was witness to this emergency procedure break-down and felt frightened and helpless as the remaining staff could only argue over who had the most to lose by going into the radiation room to recover me from the machine. It now turns out that the equipment was about to be de-commissioned. One of the nurses on duty told my wife that she was not surprised this had happened as this machine was on "its last legs and about to be taken out of commission anyway. The relevant issues here for the fda should be first. The adverse event of the eksell gamma knife equipment breaking down could easily have been prevented if ucsf had maintained the equipment properly or removed this from service. Second, that ucsf does not have the necessary stringent procedures and safeguards in place to handle gamma knife equipment breakdowns and that it seems to be acceptable procedure at ucsf to allow the neurologist leave a brain surgery procedure in the hands of a radiologist. The records show that this machine was de-commissioned immediately after my surgery.
Patient Sequence No: 1, Text Type: D, B5