Case Study

Faulty medical device causes severe burns

Simple female uterine surgery results in a disaster for the patient due to broken machine

This case involves a female patient who presented to the defending physician with complaints of heavy and painful periods. The patient returned for an 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.

Reasons for malpractice: our expert says: did the physician receive any training or was he/she relying on the representative? If the physician was properly trained to use the device, based upon the physician's and representative’s descriptions of 'unusual sounds' it does indicate a malfunction in device #2. There are similar cases involving transvaginal mesh, hip implants, kidney stone retrieval device, and infusion pumps. Typically there is a combination of issues that lead to the incident, including device manufacturing problem (quality related), the label on the device not being adequate, and the training/experience of the user/physician for the specific device in question. Pay-up doc and surgery center!

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