Design Defect Allegedly Causes Surgical Tool Malfunction During Kidney Transplant

Biomedical Engineering Expert

This case involves a 36-year-old man who underwent a laparoscopic kidney transplant in order to donate his kidney. The donor renal artery had an early branch to the upper pole, so the surgeon used an endostapler to ligate the artery. The stapler was fired and then withdrawn slowly. Rapid arterial bleeding was noted as the surgeon withdrew the stapler. The surgeon immediately made a flank incision, exposed the aorta, and held pressure until the patient was hemodynamically stable. It was alleged that the stapler was not released completely leading to the torn artery. An expert biomedical engineer familiar with endostaplers was sought to review the device in question to see if a design or manufacturing defect may have contributed to the patient’s injury.

Question(s) For Expert Witness

  • 1. Please describe your work with surgical devices such as endostaplers.
  • 2. Have you designed or conducted failure analysis of an endostapler? If so, please describe.

Expert Witness Response E-052514

I have been involved in the development of medical devices for many years at a surgical device manufacturer, and I currently serve as CEO of my own company. I am very familiar with vascular endostapling devices, having served in research and development for the surgical device manufacturer, where I led product development and design reviews for stapling devices. As a result, I can evaluate them to determine if there are design and performance defects which could result in malfunction during surgery, or whether device failure was due to operator error. I am also an inventor of several stapling device patents issued by the United States Patent & Trademark Office. There are also design control procedures that companies have to abide by. Oftentimes, when these devices are not properly checked and they have defects, these defective devices can reach a patient and something can go wrong. I have done technical design reviews and understand what can go wrong when a TA endostapler is used the wrong way in the operating theater. Sometimes, complications can be attributed to surgeon error rather than device malfunction. This is especially true in cases of stapler misfire or clamping down on the wrong area.

Expert Witness Response E-134983

I am familiar with endostaplers and their failure modes. There are many ways a stapler can malfunction, such as misfiring, closures, jams, self-locking clips, or misuse. I am familiar with all of these issues and can conduct an analysis based on the design history, documentation, and quality control (i.e. whether the quality system did or did not act on reported issues with the stapler, how they dealt with quality control). Interestingly, there are no standards for optimal trigger pressure. It is important to determine whether the stapler was maintained properly, whether it malfunctioned during the procedure, whether it had a design defect, or whether there was an issue of improper materials being used for the stapler. About a year ago, I served as an expert in a case regarding an endostapler that was somewhat similar.


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