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.
Question(s) For Expert Witness
- 1. Please discuss your background and experience working with devices as described in the case summary.
- 2. Was this device more likely than not defective?
- 3. The doctor testified that he acted appropriately and stopped the procedure when he heard the unusual sound. The MAUDE database is populated with similar events, but no indication of the actual defect. If this is not due to operator error, as the doctor believes, and seems to be borne out by reports of similar events, what potentially happened with the device that caused it to malfunction?
- 4. Have you ever served as an expert witness on a case similar to the one described above? If so, please explain.
- 5. Please tell us why you’re qualified to serve as an expert reviewer of this case.
Expert Witness Response E-007633
I am highly qualified to work as an expert on this case. I have reviewed many similar devices to the one used in this case, both while at the FDA and during my current forensic work. Additionally, prior to joining the FDA and while working at NASA, I actually reviewed a heat transfer analysis performed by a colleague for the exact same device used in the procedure for this case (uterine ablation device). The fact that device #1 failed the ‘air test’ (even on repeated tries) indicates it was defective. The fact that device #2 was first tested by the rep (and passed) then handed to the physician to use is suspicious to me. This pass requirement (test before using on patient) is usually called out in the device label. A careful review of the device label is necessary to determine that procedures were followed correctly. I am able to review more records, or the device itself, to determine if it malfunctioned.
Additionally, there are many reasons the device could have malfunctioned. On first glance, I question the training of the physician to use this particular device – 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. I have done expert witness work on a large number of cases involving medical devices. I have also reviewed 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. This case is right in my area of expertise and I am happy to assist.
Expert Witness Response E-007664
I have been on both the design and development team as well as post market investigation team for both RF and cryo-ablation products for soft tissue ablation in cardiac tissue ablation. I have no direct experience with this procedure. Since the second device passed the appropriate tests, it may be assumed to be working properly. It is unlikely that a malfunction of the disposable device occurred. A test should also be performed on the console to ensure it is delivering the appropriate energy (the sound from the device may indicate an issue). The MAUDE database is the public reporting of an issue, a follow up MDR is required from the manufacturer that should complete an investigation and root cause. It appears that many of the reports provided in the MAUDE database do not provide a complete investigation (no cause given). There are a number of hazards that could result in this harm and the manufacturer is required to estimate the risk of these issues in their risk management file for the product. Further, they are required to disclose these risks within their product labelling. Additional information would be required to provide a most likely cause (could use the manufacturer information contained within their risk management files documentation). I have not been an expert witness for any similar case. My expertise in what is required of the manufacturer for investigations and risk management of potential issues, along with experience with other RF ablation devices, provides me with an ability to ask the proper questions to help determine most likely cause of this issue.