This case involves a female patient who presented to the defending physician with complaints of heavy and painful periods. The patient returned for an endometrial ablation procedure to alleviate these symptoms, using a device manufactured by the defendant. A representative for the defendant manufacturer was present for the procedure, as the surgery center did not own the equipment that was being used. Before the procedure began, the device did not pass a basic operational test conducted by the physician, and failed several subsequent attempts at the same test. Several adjustments were recommended by the manufacturer’s representative, however the device still did not pass the test. The manufacturer’s representative then brought out a new device which passed the test immediately. The procedure was started, however a new error occurred only seconds into the procedure. The doctor corrected the issue, then restarted the procedure. The doctor stopped the ablation again, because he did not like the sound that the machine was making. The manufacturer’s representative agreed that she had not heard that sound before. The doctor removed the device and the patient went to the recovery room.
The next day, the patient reported worsening pain that did not respond to medication. The doctor instructed her to go to the ER. The patient had free air on her x-ray and had a surgical abdomen, and was taken to the OR for an exploratory laparotomy. The patient had a uterine perforation followed by a small bowel perforation secondary to the uterine ablation procedure. The injuries were consistent with a thermal injury, and the patient required several additional surgeries to treat her injuries.